fenestrated aaa endovascular graft with the h & l-b one-shot...

Zenith® Fenestrated AAA Endovascular Graft with the H & L-B One-Shot™ Introduction System InstructionsforUse

IFU-FE/5-EN

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TABLE OF CONTENTS1. DEVICE DESCRIPTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 1.1ProximalBodyGraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4 1.2ProximalBodyGraftDeliverySystem.............................................................................................................4 1.3DistalBifurcatedBodyGraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 1.4DistalBifurcatedBodyGraftDeliverySystem . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 1.5IliacLegDeliverySystem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .5 1.6AncillaryComponents. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

2. INTENDED USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

�. CONTRAINDICATIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6

4. WARNINGS AND PRECAUTIONS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.1GeneralUseInformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 4.2PatientSelection,TreatmentandFollow-Up. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.3ImplantProcedure. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 4.4MoldingBalloonUse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 4.5MRISafetyandCompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

5. SUMMARY OF CLINICAL STUDIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8

6. POTENTIAL ADVERSE EVENTS. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9

7. PATIENT SELECTION AND TREATMENT. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 7.1IndividualisationofTreatment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

8. PATIENT COUNSELING INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10

9. HOW SUPPLIED . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 9.1ProximalBodyGraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 9.2DistalBifurcatedBodyGraft. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 9.3IliacLegs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

10. CLINICAL USE INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.1PhysicianTraining. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.2InspectionPriortoUse . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.3MaterialsRequired. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.4MaterialsRecommended. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 10.5DeviceDiameterSizingGuidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 10.5.1ProximalBodyGraftDiameterSizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 10.5.2DistalIpsilateralGraftDiameterSizing.................................................................................................15 10.5.3IliacLegGraftDiameterSizing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

11. INSTRUCTIONS FOR USE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 GeneralUseInformation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Pre-ImplantDeterminants. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 PatientPreparation. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 11.1FenestratedSystem. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 11.1.1ProximalBodyGraftPreparation/Flush. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 11.1.2DistalBifurcatedBodyGraftPreparation/Flush. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 11.1.3IliacLeg(Contralateral)Preparation/Flush. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 11.1.4VascularAccessandAngiography . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 11.1.5ProximalBodyPlacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 11.1.6DockingofTopCap. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 11.1.7FenestrationStentPlacementandDeployment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 11.1.8DistalBifurcatedBodyPlacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22 11.1.9ContralateralIliacWireGuidePlacement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 11.1.10DistalBifurcatedBodyDeployment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 11.1.11IliacLeg(Contralateral)Placement. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 11.1.12DistalBifurcatedBodyDeployment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 11.1.13MoldingBalloonInsertion . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 FinalAngiogram. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26

12. IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 12.1General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 12.2ContrastandNonContrastCTRecommendations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 12.3AbdominalRadiographs. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 12.4Ultrasound. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 12.5MRISafetyandCompatibility. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 12.6AdditionalSurveillanceandTreatment. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

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ZENITH® FENESTRATED AAA ENDOVASCULAR GRAFT WITH THE H&L-B ONE-SHOT™ INTRODUCTION SYSTEMReadallinstructionscarefully.Failuretoproperlyfollowtheinstructions,warnings,andprecautionsmayleadtoseriousconsequencesor injurytothepatient.Theserecommendationsaredesignedtoserveonlyasageneralguideline.Theyarenotintendedtosupersedeinstitutionalprotocolsorprofessionalclinicaljudgmentconcerningpatientcare.

1. DEVICE DESCRIPTIONTheZenith®FenestratedAAAEndovascularGraftisamodularsystemconsistingofthreecomponents,aproximalbodygraft,adistalbifurcatedbodygraftandoneiliacleg.(Figure 1)Thegraftmodulesareconstructedoffull-thicknesswovenpolyesterfabricsewntoself-expandingstainlesssteelCook-Z®stentswithbraidedpolyesterandmonofilamentpolypropylenesuture.Themodulesarefullystentedtoprovidestabilityandtheexpansileforcenecessarytoopenthelumenofthegraftduringdeployment.Additionally,theCook-Z®stentsprovidethenecessaryattachmentandsealofthegrafttothevesselwall.Ancillarydevicessuchasmainbodyextensions,iliaclegextensions,converters,andiliacplugsmayalsoberequired.Eachindividualdevicehasitsownseparatedeliverysystem.Eachcomponentcomes ina rangeof lengthsanddiameterswhichallows thephysician to tailor thedevicetoindividualpatientanatomiesandselectthebestproximalanddistalfixationsites.

1.1 Proximal Body GraftThe bare suprarenal stent at the proximal end of the proximal body graft contains barbs that areplacedat3mmincrementsforadditionalfixationofthedevice.Thisgraftcontainsuptothreepreciselylocatedholes(fenestration(s)),andcut-outsfromtheproximalmargin(scallop(s))ofthegraftmaterial.(Figure 2)ThepurposeofthesescallopsandfenestrationsistoallowtheproximalmarginofthedevicetosithigherthanstandardAAAdevicesandallowuninterruptedbloodflowtobranchvesselsoftheaortasuchastherenalandsuperiormesentericarteries.To facilitate fluoroscopic visualisation of the stent graft, gold radiopaque markers are positioned asfollows:oneonthelateralaspectofthemostdistalstentandfourinacircumferentialorientationwithin1mmofthemostsuperioraspectofthegraftmaterial.Tofacilitateorientationofthegraftduringdeploymentgoldradiopaquemarkersarepositionedontheanteriorandposteriorsurfacesofthegraft,belowthelevelofthefenestrations.Additionalgoldmarkersarepositionedanteriorlyintheshapeofatickorcheckmarker.

1.2 Proximal Body Graft Delivery System TheZenith®FenestratedAAAEndovascularProximalBodyGraft isshippedpreloadedontotheH&L-BOne-Shot™IntroductionSystem.(Figure �)Ithassequentialdeploymentmethodwithbuilt-infeaturestoprovidecontinuouscontrolofthegraftthroughoutthedeploymentprocedure.

Figure 1. The Zenith® Fenestrated AAA Endovascular Graft

Distal Bifurcated BodyIliac Leg Proximal Body

Gold Radiopaque

Marker

Anterior Gold

Markers

Suprarenal Stent

Scallop

Proximal Body

Fenestration(s)

Tick Marker

Figure 2. Zenith® Fenestrated AAA Endovascular Graft (Proximal Body)

Gold Radiopaque Markers (4)

Figure �. H&L-B One-Shot™ Introduction System (Proximal Body)

HUB PIN VISE

SAFETY LOCKS

TOP CAP INNER

CANNULAGOLD

TRIGGER-WIRE RELEASE

MECHANISM

BLACK TRIGGER-WIRE

RELEASE MECHANISM WHITE


MECHANISM

STOPCOCKCONNECTING

TUBE

SHEATH

PROXIMAL BODY GRAFT

DILATOR TIPSHEATH SIDEPORT

HEMOSTATIC VALVECAPTOR™

HEMOSTATIC VALVE

GREY POSITIONER

PEEL-AWAY® SHEATH

5

Thegraftisreducedindiameterbyanindependentwiretiedtodiameterreducingties,whichallowsthegrafttobemanipulatedwithintheaortatoallowaccuratepositioningofthegraft,whichenablesthefenestration(s)tolineupwiththedesiredarteries.Thebaresuprarenalstentisconstrainedwithinatopcapandheldbyatrigger-wire.Thedistalendofthegraftisalsoattachedtothedeliverysystemandheldbyanindependentwire.TheH&L-BOne-Shot™IntroductionSystemenablesprecisepositioningandallowsreadjustmentofthefinalgraftpositionbeforedeploymentofthebarebarbedsuprarenalstent.Thedeliverysystemusesa20French(6.9mmI.D.)H&L-BOne-Shot™IntroductionSystem.AllSystemsarecompatiblewitha.035inch(0.89mm)wireguide.Foraddedhemostasis,theCaptor™HemostaticValvecanbeloosenedortightenedfortheintroductionand/orremovalofancillarydevicesintoandoutofthesheath.

1.3Distal Bifurcated Body Graft The Zenith® Fenestrated AAA Endovascular Distal Bifurcated Body Graft has one long ipsilateral iliaclimbandoneshortcontralaterallimb.Tofacilitatefluoroscopicvisualisationofthestentgraft,thereisaradiopaquemarkeratthegraftbifurcationandacontralaterallimbradiopaquemarkeratthedistalendofthecontralaterallimb.(Figure 4)

1.4 Distal Bifurcated Body Graft Delivery SystemTheZenith®FenestratedAAAEndovascularDistalBifurcatedBodyGraftisshippedpreloadedontotheH&L-BOne-Shot™IntroductionSystem.(Figure 5)Thebifurcatedgrafthasonelongipsilaterallimbandoneshortcontralaterallimb.Thereisaradiopaquemarkeratthegraftbifurcationandaradiopaquemarkeratthedistalendofthecontralateral limb. Ithasasequentialdeploymentmethodwithbuilt-in featurestoprovidecontinuouscontrolofthegraftthroughoutthedeploymentprocedure.Boththeproximalanddistalsegmentsofthegraftareattachedtothedeliverysystemandheldbyindependentwires.TheH&L-BOneShot™IntroductionSystemenablesprecisepositioningandallowsreadjustmentofthegraftpositionbeforedeploymentofthegraft.Thedeliverysystemusesa20French(6.9mmI.D.)H&L-BOne-Shot™IntroductionSystem.Allsystemsarecompatiblewitha.035inch(0.89mm)wireguide.Foraddedhemostasis,theCaptor™HemostaticValvecanbeloosenedortightenedfortheintroductionand/orremovalofancillarydevicesintoandoutofthesheath.

1.5Iliac Leg Delivery System The Zenith® AAA Endovascular Iliac Leg Graft is shipped preloaded onto the H&L-B One-Shot™IntroductionSystem.(Figure 6)Thedeliverysystemisdesignedforeaseofusewithminimalpreparation.Theiliaclegdeliverysystemuses14French(4.8mmI.D.)or16French(5.6mmI.D.)H&L-BOne-Shot™IntroductionSystems.Allsystemsarecompatiblewitha.035inch(0.89mm)wireguide.

Figure 4. Zenith® Fenestrated AAA Endovascular Graft (Distal Body)

Gold Radiopaque

Markers

Distal Bifurcated Body Gold Radiopaque

Marker

Figure 5. H&L-B One-Shot™ Introduction System (Distal Body)

HUB PIN VISE

SAFETY LOCKS

TOP CAP INNER

CANNULA

BLACK TRIGGER-WIRE

RELEASE MECHANISM WHITE


MECHANISM

STOPCOCKCONNECTING

TUBE

SHEATH

DISTAL BIFURCATED BODY GRAFT

DILATOR TIPHEMOSTATIC VALVECAPTOR™

HEMOSTATIC VALVE

GREY POSITIONER

PEEL-AWAY® SHEATH

Figure 6. H&L-B One-Shot™ Introduction System (Iliac Legs)

HUB PIN VISE

INNER CANNULA

STOPCOCK

CONNECTING TUBE

SHEATH

ENDOVASCULAR ILIAC LEG GRAFT

DILATOR TIP

HEMOSTATIC VALVE

GREY POSITIONER

PEEL-AWAY® SHEATH

SHEATH SIDEPORT

6

1.6 Ancillary ComponentsAdditionalancillarycomponents(mainbodyextensions,iliaclegextensions,converters,andiliacplugs)areavailable.(Figure 7)Zenith®ancillarycomponentsareconstructedfromthesamepolyesterfabric,self-expandingstainlesssteelCook-Z®stents,andpolypropylenesutureusedinconstructingtheprincipalgraftmodules.RefertoInstructionsforUseenclosedindevicepackaging.

2. INTENDED USE The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System isindicatedforthetreatmentof infrarenalabdominalaorticaneurysms(AAAs) inhigh-riskpatientswhoarenotsuitableforconventionalopensurgicalrepairorwhoarenotsuitableforrepairwithastandardZenith®EndovascularGraft,whentheaneurysmaldiseaseextendsuptotheleveloftherenalarteries.Thepatientmusthaveaneurysmalmorphologysuitableforendovascularrepair,including:•Adequatefemoral/iliacaccesscompatiblewiththerequireddeliverysystems;•Anon-aneurysmalinfrarenalaorticsegment(neck)proximaltotheaneurysmwith:•Alengthofatleast4mm,i.e.atleast4mmcircumferentialwallcontactaroundfenestrationsand/or

limitsofscallop;•Adiametermeasuredouterwalltoouterwallofnogreaterthan31mmandnolessthan19mm;•Ananglelessthan45degreesrelativetothelongaxisoftheaneurysm;and•Ananglelessthan45degreesrelativetotheaxisofthesuprarenalaorta.•Anipsilateraliliacarterydistalfixationsitegreaterthan10mminlengthand9–21mmindiameter

(measuredouterwalltoouterwall);and•Acontralateraliliacarterydistalfixationsitegreaterthan10mminlengthand7–21mmindiameter

(measuredouterwalltoouterwall).

3. CONTRAINDICATIONS There are no known contraindications for these devices.

4. WARNINGS AND PRECAUTIONS

4.1General Use Information•Readallinstructionscarefully.Failuretoproperlyfollowtheinstructions,warningsandprecautionsmay

leadtoseriousconsequencesorinjurytothepatient.•Fenestratedgraftsaremadetoacustomiseddesigntoaspecificationrequestedby the responsible

Physician,andaretailoredtoaspecificpatient'sanatomy.•TheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystemmust

onlybeusedbyphysiciansandteamstrainedinvascularinterventionaltechniquesandintheuseofthisdevice.

•Lackofnon-contrastCTimagingmayresultinfailuretoappreciateiliacoraorticcalcification,whichmayprecludeaccessorreliabledevicefixationandseal.

•Preprocedureimagingreconstructionthickness>3mmmayresultinsub-optimaldevicesizing,orinfailuretoappreciatefocalstenosisfromCT

•The long-term performance and safety of endovascular grafts has not yet been established.As a result, life-long, regular follow-up must be undertaken in all patients to assess the ongoingperformanceoftheZenith®FenestratedAAAEndovascularGraft.Patientswithspecificclinicalfindings(e.g.,endoleaks,enlarginganeurysmsorchangesinthestructureorpositionoftheendovasculargraft)shouldreceiveenhancedfollow-up.

Specificfollow-upguidelinesaredescribedinSection12.•Afterendovasculargraftplacement,patientsshouldberegularlymonitoredforperigraftflow,aneurysm

growthorchangesinthestructureorpositionoftheendovasculargraft. Ataminimum,annualimagingisrequired,including: 1)abdominalradiographstoexaminedeviceintegrity(separationbetweencomponents,stentfracture

orbarbseparation)and2)contrastandnon-contrastCTtoexamineaneurysmchanges,perigraftflow,patency,tortuosityandprogressivedisease.

Figure 7. Zenith® Fenestrated AAA Endovascular Graft (Ancillary Components)

ILIAC PLUG

CONVERTER

MAIN BODY EXTENSION

ILIAC LEG EXTENSION

7

Ifrenalcomplicationsorotherfactorsprecludetheuseofimagecontrastmedia,abdominalradiographsandduplexultrasoundmayprovidesimilarinformation.

•TheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystemisnotrecommendedinpatientsunabletoundergo,orwhowillnotbecompliantwiththenecessarypreoperativeandpost-operativeimagingandimplantationstudiesasdescribedinSection12,ImagingGuidelinesandPost-OperativeFollow-Up.

• Interventionorconversiontostandardopensurgicalrepairfollowinginitialendovascularrepairshouldbeconsideredforpatientsexperiencingenlarginganeurysms,unacceptabledecreaseinfixationlength(vesselandcomponentoverlap)and/orendoleak.

Anincreaseinaneurysmsizeand/orpersistentendoleakmayleadtoaneurysmrupture.•Patients experiencing reducedblood flow through thegraft limb and/or leaksmaybe required to

undergosecondaryinter-ventionsorsurgicalprocedures.•Alwayshaveavascularsurgeryteamavailableduringimplantationorreinterventionproceduresinthe

eventthatconversiontoopensurgicalrepairisnecessary.

4.2 Patient Selection, Treatment and Follow-Up •Access vessel diameter (measured inner wall to inner wall) and morphology (minimal tortuosity,

occlusive disease, and/or calcification) should be compatible with vascular access techniques anddeliverysystemsoftheprofileofa14French(5.5mmO.D.)to20French(8.1mmO.D.)vascularintroducersheath.

Vesselsthataresignificantlycalcified,occlusive,tortuousorthrombus-linedmayprecludeplacementoftheendovasculargraftand/ormayincreasetheriskofembolisation.

•Keyanatomicelementsthatmayaffectsuccessfulexclusionoftheaneurysmincludesevereproximalneckangulation(>45degreesforinfrarenalnecktoaxisofAAAor>45degreesforsuprarenalneckrelative to the immediate infrarenalneck); shortproximalaorticneck (<4mm);greater than10%increaseindiameterover15mmofproximalaorticnecklength;andcircumferentialthrombusand/orcalcificationatthearterialimplantationsites,specificallytheproximalaorticneckanddistaliliacarteryinterface.

Irregularcalcificationand/orplaquemaycompromisethefixationandsealingoftheimplantationsites.Necksexhibitingthesekeyanatomicelementsmaybemoreconducivetograftmigration.

•TheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystemisnotrecommendedinpatientswhocannottoleratecontrastagentsnecessaryforintra-operativeandpost-operativefollow-upimaging.

•TheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystemisnotrecommendedinpatientsexceedingweightand/orsizelimits,whichcompromiseorpreventthenecessaryimagingrequirements.

•TheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystemisnotrecommendedinpatientswithknownsensitivitiesorallergiestostainlesssteel,polyester,nitinol,solder(tin,silver),polypropyleneorgold.

•Patientswithasystemicinfectionmaybeatincreasedriskofendovasculargraftinfection.• Inabilitytomaintainpatencyofatleastoneinternaliliacarteryorocclusionofanindispensableinferior

mesentericarterymayincreasetheriskofpelvic/bowelischemia.•Multiplelarge,patentlumbararteries,muralthrombusandapatentinferiormesentericarterymayall

predisposeapatienttoTypeIIendoleaks.PatientswithuncorrectablecoagulopathymayalsohaveanincreasedriskofTypeIIendoleakorbleedingcomplications.

4.3Implant Procedure •Systemicanticoagulationshouldbeusedduringthe implantationprocedurebasedonhospitaland

physician preferred protocol. If heparin is contraindicated, an alternative anticoagulant should beconsidered.

•Minimisehandlingoftheconstrainedendoprosthesisduringpreparationandinsertiontodecreasetheriskofendoprosthesiscontaminationandinfection.

•Maintainwireguidepositionduringdeliverysysteminsertion.•Donotbendorkinkthedeliverysystem.Doingsomaycausedamagetothedeliverysystemandthe

Zenith®FenestratedAAAEndovascularGraft.•Always use fluoroscopy for guidance, delivery and observation of any Zenith® Fenestrated AAA

EndovascularGraftcomponentswithinthevasculature.•TheuseoftheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™Introduction

Systemrequiresadministrationofintravascularcontrast. Patientswithpre-existingrenalinsufficiencymayhaveanincreasedriskofrenalfailurepost-operatively.

Careshouldbetakentolimittheamountofcontrastmediausedduringtheprocedure.•Toavoidanytwistintheendovasculargraft,duringanyrotationofthedeliverysystem,becarefulto

rotateallofthecomponentsofthesystemtogether(fromoutersheathtoinnercannula).• Inaccurateplacementand/or incompletesealingoftheZenith®FenestratedAAAEndovascularGraft

withinthevesselmayresult in increasedriskofendoleak,migrationor inadvertentocclusionoftherenalorinternaliliacarteries.Renalarterypatencymustbemaintainedtoprevent/reducetheriskofrenalfailureandsubsequentcomplications.

• InadequatefixationoftheZenith®FenestratedAAAEndovascularGraftmayresultinincreasedriskofmigrationofthestentgraft.

Incorrectdeploymentormigrationoftheendoprosthesismayrequiresurgicalintervention.•TheZenith®FenestratedAAAEndovascularGraftincorporatesasuprarenalstentwithfixationbarbs. Exercise extremecautionwhenmanipulating interventionaldevices in the regionof the suprarenal

stent.

8

•Donotcontinueadvancinganyportionofthedeliverysystemifresistanceisfeltduringadvancementofthewireguideordeliverysystem.

Stopandassessthecauseofresistance.Vesselorcatheterdamagemayoccur.Exerciseparticularcareinareasofstenosis,intravascularthrombosisorincalcifiedortortuousvessels.

•Unless medically indicated, do not deploy the Zenith® Fenestrated AAA Endovascular Graft in alocation thatwill occlude arteriesnecessary to supplyblood flow toorgansor extremities.Donotcover significant renal or mesenteric arteries (exception is the inferior mesenteric arteryonly if the superior mesenteric artery and the anastomosis of Riolan are patent and functioning correctly)withtheendoprosthesis.Vesselocclusionmayoccur.ClinicalstudieshaveidentifiedthatwithuseoftheZenith®FenestratedAAAEndovascularGraftthereisariskofrenalimpairment/loss(whichcouldleadtoaneedfordialysis).

ClinicalstudieshaveshownthatthisriskisreducedwhentherenalarteriesarestentedaspartoftheproceduretoimplantaZenith®FenestratedAAAEndovascularGraft.

StentingoftherenalarteriesisthereforestronglyrecommendedwithuseoftheZenith®FenestratedAAAEndovascularGrafttoreducetheriskofrenalimpairment/loss.

•Take care during manipulation of catheters, wires and sheaths within an aneurysm. Significantdisturbancesmaydislodgefragmentsofthrombus,whichcancausedistalembolisation.

•Beforedeploymentofthesuprarenalstent,verifythatthepositionoftheaccesswireguideextendsjustdistaltotheaorticarch.

•Verifythatthepredeterminedcontralateraliliaclegisselectedforinsertiononthecontralateralsideofthepatientbeforeimplantation.

•Careshouldbetakennottodamagethegraftordisturbgraftpositioningaftergraftplacementintheeventreinstrumentationofthegraftisnecessary.

4.4 Molding Balloon Use •Priortomoldinginthevicinityofanyfenestrationstent(s)confirmthattheaorticsectionofthestent

hasbeenflared.•Confirmcompletedeflationofballoonpriortorepositioning.•Donotinflateballooniniliacvesseloutsideofgraft.

4.5 MRI Safety and Compatibility •TheMRsafetyandcompatibilityoftheZenith®AAAEndovascularGrafthasbeenevaluatedthrough

benchtestinginMRIsystemswithstaticfieldsof1.5Tesla,gradientmagneticfieldsof20Tesla/secondandwholebodyaveragedspecificabsorptionrate(SAR)of1.2W/kgfor30minutesofimaging.TheZenith®AAAEndovascularGraftwasfoundtoexhibitsignificantdeflectionandtorqueofthestainlesssteelmetallic componentof theendovasculargraft and thereforedidnotmeet standard 'MRSafe'benchtestcriteria.

•Adverse events have not been reported clinically in patients who have undergone MRI. However,sufficientdataarenotavailabletodemonstrateMRIsafetyandtheremaybepotentialrisks(e.g.,devicemigration,vesseldamage)thatcouldbeassociatedwithforcesappliedtothemetalliccomponentsoftheZenith®AAAEndovascularGraft.

Therefore,acarefulassessmentofthesepotentialrisksandthepotentialbenefitstothepatientshouldbe completedprior touseofMR imaging. In addition the facility forMRI shouldbe appropriatelyselectedtoallowforpromptinterventionifnecessary.

•TheZenith®AAAEndovascularGraftmayaffectimagequality(imageartifact)dependingonthepulsesequencethatisusedforMRimaging.

NOTE:MRIlabellingprimarilybaseduponclinicalexperienceandbenchtestingwiththeZenith®AAAEndovascularGraftwhichismadefromstentsofthesamemetal.

5. SUMMARY OF CLINICAL STUDIESA review of the available clinical data identified six (6) clinical studies relating to use of the Zenith®FenestratedAAAEndovascularGraftandthree(3)pivotalclinicalstudiesrelatingtouseofthestandardZenith®EndovascularGraftcomparedtoconventionalopensurgicalrepair.The results from the six (6) clinical studies involving theZenith®FenestratedAAAEndovascularGraftwereconsistentwithrespect toboththeperformanceandthesafetyof theZenith®FenestratedAAAEndovascularGraft.Overall,technical,proceduralandtreatmentsuccessallexceeded80%.Therewerenoconversionstoconventionalopensurgicalrepairinanyoftheclinicalstudiesnorwerethereanyruptures.Therateofendoleaksvariedbetweentheclinical studiesandrangedfrom6.9%to32.3%.Thehighrate(32.3%,n=21)seeninone(1)oftheclinicalstudiesrepresentedthoseidentifiedintra-operatively,14ofwhichhadresolvedbythetimeofdischargeandonly3(4.6%)ofwhichremainedunresolvedat1monthfollow-up(alloftheseweretypeIIendoleaks).Theseresultswereconsistentwiththeendoleaksseenintheotherclinicalstudies,whichwerealsotypeIIendoleaksandoccurredduringsimilarfollow-upperiods.

9

The percentage of patients with renal impairment (either temporary or permanent) varied between5.0% and 23.6%. However, a number of these cases occurred during the early experience with theZenith® Fenestrated AAA Endovascular Graft before the importance of renal stenting was identified.(ThisriskisreducedwhentherenalarteriesarestentedaspartoftheproceduretoimplantaZenith®

FenestratedAAAEndovascularGraft.)Furthermore,therewereveryfewpatientsintotalwhorequiredeithertemporaryorpermanentdialysis.The 30-day and all graft-related mortality rates ranged between 1.4% to 3.5% and 4.6% to 5.6%,respectively. In absolute terms, there were only three (3) 30-day deaths and seven (7) graft-relateddeathsintotal.

6. POTENTIAL ADVERSE EVENTSUseoftheZenith®FenestratedAAAEndovascularGraftposesthefollowingpotentialrisksinadditiontothoseassociatedwithuseofastandardZenith®EndovascularGraft:•Organimpairment/lossduetoside-branchvesselocclusion(inparticular,renaland/orgastrointestinal

impairment/loss).Clinicalstudieshave identifiedthatwithuseoftheZenith®FenestratedAAAEndovascularGraft thereisariskofrenalimpairment/loss(whichcouldleadtoaneedfordialysis).ClinicalstudieshaveshownthatthisriskisreducedwhentherenalarteriesarestentedaspartoftheproceduretoimplantaZenith®FenestratedAAAEndovascularGraft.StentingoftherenalarteriesisthereforestronglyrecommendedwithuseoftheZenith®FenestratedAAAEndovascularGrafttoreducetheriskofrenalimpairment/loss.

Otheradverseeventsthatmayoccurand/orrequireinterventioninclude,butarenotlimitedto:

•Amputation•Anestheticcomplicationsandsubsequentattendantproblems(e.g.,aspiration)•Aneurysmenlargement•Aneurysmruptureanddeath•Aorticdamage,includingperforation,dissection,bleeding,ruptureanddeath•Arterialorvenousthrombosisand/orpseudoaneurysm•Arteriovenousfistula•Bleeding,hematomaorcoagulopathy•Bowelcomplications(e.g.,ileus,transientischemia,infarction,necrosis)•Cardiaccomplicationsandsubsequentattendantproblems (e.g.,arrhythmia,myocardial infarction,

congestiveheartfailure,hypotension,hypertension)•Claudication(e.g.buttock,lowerlimb)•Death•Edema•Embolisation(microandmacro)withtransientorpermanentischemiaorinfarction•Endoleak•Endoprosthesis: improper component placement; incomplete component deployment; component

migration; suturebreak;occlusion; infection; stent fracture;graftmaterialwear;dilatation; erosion;puncture;perigraftflow;barbseparationandcorrosion

•Feverandlocalisedinflammation•Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula,

incontinence,hematuria,infection)•Graftornativevesselocclusion•Hepaticfailure• Impotence• Infectionoftheaneurysm,deviceoraccesssite,includingabscessformation,transientfeverandpain•Lymphaticcomplicationsandsubsequentattendantproblems(e.g.,lymphfistula)•Neurologiclocalorsystemiccomplicationsandsubsequentattendantproblems(e.g.,stroke,transient

ischemicattack,paraplegia,paraparesis,paralysis)•Pulmonary/respiratorycomplicationsandsubsequentattendantproblems(e.g.,pneumonia,respiratory

failure,prolongedintubation)•Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity,

insufficiency,failure)•Surgicalconversiontoopenrepair•Vascularaccesssitecomplications,includinginfection,pain,hematoma,pseudoaneurysm,arteriovenous

fistula•Vesseldamage•Woundcomplicationsandsubsequentattendantproblems(e.g.,dehiscence,infection)•Vascularspasmorvasculartrauma(e.g.,iliofemoralvesseldissection,bleeding,rupture,death)

10

7. PATIENT SELECTION AND TREATMENT(SeeWarningsandPrecautions)

7.1 Individualisation of Treatment Each patient must be evaluated on an individual basis with careful consideration given to both thepotentialbenefitsandspecificrisksassociatedwiththeprocedure.Considerations regarding the use of the Zenith® Fenestrated AAA Endovascular Graft (see Warnings)include:•Riskofaneurysmrupture•Morbidityandmortalityassociatedwithconventionalsurgicalrepair•Comorbidities•Sizeofaneurysm•Historyofrenalfailure•Lifeexpectancy•Anaestheticrisk•Ageofpatient• Iliofemoral access vessel size and morphology (minimal thrombus, calcification and/or tortuosity)

should be compatible with vascular access techniques and accessories of the delivery profile of a14French(5.5mmO.D.)to20French(8.1mmO.D.)vascularintroducersheath.

•Non-aneurysmalinfrarenalaorticsegment(neck)proximaltotheaneurysm:•withalengthofatleast4mm,•with a diameter measured outer wall to outer wall of no greater than 31 mm and no less than

19mm,•withananglelessthan45degreesrelativetothelongaxisoftheaneurysm,and•withananglelessthan45degreesrelativetotheaxisofthesuprarenalaorta.• Ipsilateral iliac artery distal fixation site greater than 10 mm in length and 9-21 mm in diameter

(measuredouterwalltoouterwall).•Contralateral iliacarterydistalfixationsitegreaterthan10mminlengthand7-21mmindiameter

(measuredouterwalltoouterwall).•Freedomfromsignificant femoral/iliacarteryocclusivediseasethatwould impedeflowthroughthe

endovasculargraft.Thefinaltreatmentdecisionisatthediscretionofthephysicianandpatient.

8. PATIENT COUNSELING INFORMATIONThephysicianandpatient(and/orfamilymembers)shouldreviewtherisksandbenefitswhendiscussingthisendovasculardeviceandprocedureincluding:•Risksanddifferencesbetweenendovascularrepairandsurgicalrepair.•Potentialadvantagesoftraditionalopensurgicalrepair.•Potentialadvantagesofendovascularrepair.Thepossibilitythatsubsequentinterventionaloropensurgicalrepairoftheaneurysmmayberequiredafterinitialendovascularrepair.Inadditiontotherisksandbenefitsofanendovascularrepair,thephysicianshouldassessthepatient'scommitmentandcompliancetopost-operativefollow-upasnecessarytoensurecontinuingsafeandeffectiveresults.Listedbelowareadditionaltopicstodiscusswiththepatientastoexpectationsafteranendovascularrepair:•The long-term performance and safety of endovascular grafts has not yet been established.

As a result, life-long, regular follow-up must be undertaken in all patients to assess the ongoingperformanceoftheZenith®FenestratedAAAEndovascularGraft.Patientswithspecificclinicalfindings(e.g., endoleaks, enlarging aneurysms, or changes in the structure or position of the endovasculargraft)shouldreceiveenhancedfollow-up.Specific follow-upguidelinesaredescribed inSection12,ImagingGuidelinesandPost-OperativeFollow-Up.

9. HOW SUPPLIED The Zenith® Fenestrated AAA Endovascular Graft is supplied sterile and pre-loaded in peel-openpackages.Thedeviceisintendedforsingleuseonly.Donotre-sterilisethedevice.Inspectthedeviceandpackagingtoverify thatnodamagehasoccurredasa resultof shipping.Donotuse thisdevice ifdamagehasoccurredorifthesterilisationbarrierhasbeendamagedorbroken.Ifdamagehasoccurred,donotusetheproductandreturntoyourCookrepresentativeoryournearestCookoffice.Priortouse,verifycorrectdevices(quantityandsize)havebeensuppliedforthepatientbymatchingthedevicetotheorderprescribedbythephysicianforthatparticularpatient.Donotuseaftertheexpirationdateprintedonthelabel.Storeinacooldryplace.TheZenith®FenestratedAAAEndovascularGraftanddeliverysystemsareavailableinthelengthsanddiametersdetailedoveronpages11to13.

11

9.1 Proximal Body Graft

ZFEN-P-1-24-76 24mm 76mm 20Fr (6.9mm/8.1mm) 50cm

















































Reorder Number

Proximal Body Diameter

Proximal Body Length

Introduction SheathFrench Size (I.D. / O.D.)

Introduction Sheath Length

12

9.2 Distal Bifurcated Body Graft

ZFEN-D-12-28-76 12mm 76mm 28mm 20Fr (6.9mm/8.1mm) 40cm












































Reorder Number

Ipsilateral Leg Diameter

Distal Body Length


Introduction Sheath Length

Distal Leg Length

1�

9.3 Iliac Legs

TFLE-8-37 8mm 37mm 14Fr (4.8mm/5.5mm)

TFLE-8-54 8mm 54mm 14Fr (4.8mm/5.5mm)

TFLE-8-71 8mm 71mm 14Fr (4.8mm/5.5mm)

TFLE-8-88 8mm 88mm 14Fr (4.8mm/5.5mm)

TFLE-8-105 8mm 105mm 14Fr (4.8mm/5.5mm)

TFLE-8-122 8mm 122mm 14Fr (4.8mm/5.5mm)

TFLE-10-37 10mm 37mm 14Fr (4.8mm/5.5mm)

TFLE-10-54 10mm 54mm 14Fr (4.8mm/5.5mm)

TFLE-10-71 10mm 71mm 14Fr (4.8mm/5.5mm)

TFLE-10-88 10mm 88mm 14Fr (4.8mm/5.5mm)

TFLE-10-105 10mm 105mm 14Fr (4.8mm/5.5mm)

TFLE-10-122 10mm 122mm 14Fr (4.8mm/5.5mm)

TFLE-12-37 12mm 37mm 14Fr (4.8mm/5.5mm)

TFLE-12-54 12mm 54mm 14Fr (4.8mm/5.5mm)

TFLE-12-71 12mm 71mm 14Fr (4.8mm/5.5mm)

TFLE-12-88 12mm 88mm 14Fr (4.8mm/5.5mm)

TFLE-12-105 12mm 105mm 14Fr (4.8mm/5.5mm)

TFLE-12-122 12mm 122mm 14Fr (4.8mm/5.5mm)

TFLE-14-37 14mm 37mm 14Fr (4.8mm/5.5mm)

TFLE-14-54 14mm 54mm 14Fr (4.8mm/5.5mm)

TFLE-14-71 14mm 71mm 14Fr (4.8mm/5.5mm)

TFLE-14-88 14mm 88mm 14Fr (4.8mm/5.5mm)

TFLE-16-37 16mm 37mm 14Fr (4.8mm/5.5mm)

TFLE-16-54 16mm 54mm 14Fr (4.8mm/5.5mm)

TFLE-16-71 16mm 71mm 14Fr (4.8mm/5.5mm)

TFLE-16-88 16mm 88mm 14Fr (4.8mm/5.5mm)

TFLE-18-37 18mm 37mm 16Fr (5.6mm/6.2mm)

TFLE-18-54 18mm 54mm 16Fr (5.6mm/6.2mm)

TFLE-18-71 18mm 71mm 16Fr (5.6mm/6.2mm)

TFLE-18-88 18mm 88mm 16Fr (5.6mm/6.2mm)

TFLE-20-37 20mm 37mm 16Fr (5.6mm/6.2mm)

TFLE-20-54 20mm 54mm 16Fr (5.6mm/6.2mm)

TFLE-20-71 20mm 71mm 16Fr (5.6mm/6.2mm)

TFLE-20-88 20mm 88mm 16Fr (5.6mm/6.2mm)

TFLE-22-37 22mm 37mm 16Fr (5.6mm/6.2mm)

TFLE-22-54 22mm 54mm 16Fr (5.6mm/6.2mm)

TFLE-22-71 22mm 71mm 16Fr (5.6mm/6.2mm)

TFLE-22-88 22mm 88mm 16Fr (5.6mm/6.2mm)

TFLE-24-37 24mm 37mm 16Fr (5.6mm/6.2mm)

TFLE-24-54 24mm 54mm 16Fr (5.6mm/6.2mm)

TFLE-24-71 24mm 71mm 16Fr (5.6mm/6.2mm)

TFLE-24-88 24mm 88mm 16Fr (5.6mm/6.2mm)

Reorder Number

Iliac Leg Diameter

Iliac Leg Length


14

10. CLINICAL USE INFORMATION

10.1 Physician TrainingCAUTION: Always have a vascular surgery team available during implantation or reintervention procedures in the event that conversion to open surgical repair is necessary. CAUTION: The Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System MUST only be used by physicians and teams trained in vascular interventional techniques and in the use of this device. The recommended skill/knowledge requirements for physicians using the Zenith® Fenestrated AAA Endovascular Graft with the H&L-B One-Shot™ Introduction System are outlined below: Patient Selection:•Knowledgeofthenaturalhistoryofabdominalaorticaneurysms(AAA)andco-morbiditiesassociated

withAAArepair.•Knowledgeofradiographicimageinterpretation,deviceselectionandsizing.A multi-disciplinary team that has combined procedural experience with:•Femoralcutdown,arteriotomyandrepair•Percutaneousaccessandclosuretechniques•Non-selectiveandselectivewireguideandcathetertechniques•Fluoroscopicandangiographicimageinterpretation•Embolisation•Angioplasty•Endovascularstentplacement•Snaretechniques•Appropriateuseofradiographiccontrastmaterial•Techniquestominimiseradiationexposure•Expertiseinnecessarypatientfollow-upmodalities

10.2 Inspection Prior to Use Inspect the device and packaging to verify that no damage has occurred as a result of shipping.Donotusethisdeviceifdamagehasoccurredorifthesterilisationbarrierhasbeendamagedorbroken.Ifdamagehasoccurred,donotusetheproductandreturntothenearestCookofficeorRepresentative.Priortouse,verifycorrectdevices(quantityandsize)havebeensuppliedforthepatientbymatchingthedevicetotheorderprescribedbythephysicianforthatparticularpatient.

10.3 Materials Required(Notincludedin3-piecemodularsystem)•Zenith®AAAEndovascularGraftAncillaryKit•Fluoroscopewithdigitalangiographycapabilities(C-armorfixedunit)•Contrastmedia•Syringe•Heparinisedsalinesolution

10.4 Materials Recommended(Notincludedin3-piecemodularsystem)Thefollowingproductsarerecommended:• .035inch(0.89mm)extrastiffwireguide,260cm;forexample: •CookAmplatzUltraStiffWireGuides(AUS) •CookLunderquistExtraStiffWireGuides(LES)• .035inch(0.89mm)standardwireguide;forexample: •Cook.035inchwireguides •CookNimble™WireGuides• MoldingBalloons• Introducersets;forexample: •CookCheck-Flo®IntroducerSets •CookExtraLargeCheck-Flo®IntroducerSets •CookFlexor®BalkinUp&Over®ContralateralIntroducers• Sizingcatheter;forexample: •CookAurous®CentimeterSizingCatheters• Angiographicradiopaquetipcatheters;forexample: •CookBeacon®TipAngiographicCatheters •CookRoyalFlush®CatheterswithBeacon®Tip• Entryneedles;forexample: •Cooksinglewallentryneedles

15

10.5 Device Diameter Sizing Guidelines Thechoiceofdiametershouldbedeterminedfromtheouterwalltoouterwallvesseldiameterandnotthelumendiameter.Undersizingoroversizingmayresultinincompletesealingorcomprisedflow.

10.5.1 Proximal Body Graft Diameter Sizing

19mm 24mm 20Fr (6.9mm/8.1mm) 20mm 24mm 20Fr (6.9mm/8.1mm) 21mm 24mm 20Fr (6.9mm/8.1mm) 21mm 26mm 20Fr (6.9mm/8.1mm) 22mm 26mm 20Fr (6.9mm/8.1mm) 23mm 28mm 20Fr (6.9mm/8.1mm) 24mm 28mm 20Fr (6.9mm/8.1mm) 24mm 30mm 20Fr (6.9mm/8.1mm) 25mm 30mm 20Fr (6.9mm/8.1mm) 26mm 30mm 20Fr (6.9mm/8.1mm) 26mm 32mm 20Fr (6.9mm/8.1mm) 27mm 32mm 20Fr (6.9mm/8.1mm) 28mm 32mm 20Fr (6.9mm/8.1mm) 28mm 34mm 20Fr (6.9mm/8.1mm) 29mm 34mm 20Fr (6.9mm/8.1mm) 29mm 36mm 20Fr (6.9mm/8.1mm) 30mm 36mm 20Fr (6.9mm/8.1mm) 31mm 36mm 20Fr (6.9mm/8.1mm)

10.5.2 Distal Ipsilateral Graft Diameter Sizing

9mm 12mm 20Fr (6.9mm/8.1mm) 10mm 12mm 20Fr (6.9mm/8.1mm) 11mm 12mm 20Fr (6.9mm/8.1mm) 12mm 16mm 20Fr (6.9mm/8.1mm) 13mm 16mm 20Fr (6.9mm/8.1mm) 14mm 16mm 20Fr (6.9mm/8.1mm) 15mm 16mm 20Fr (6.9mm/8.1mm) 15mm 20mm 20Fr (6.9mm/8.1mm) 16mm 20mm 20Fr (6.9mm/8.1mm) 17mm 20mm 20Fr (6.9mm/8.1mm) 18mm 20mm 20Fr (6.9mm/8.1mm) 18mm 24mm 20Fr (6.9mm/8.1mm) 19mm 24mm 20Fr (6.9mm/8.1mm) 20mm 24mm 20Fr (6.9mm/8.1mm) 21mm 24mm 20Fr (6.9mm/8.1mm)

10.5.3 Iliac Leg Graft Diameter Sizing

7mm 8mm 14Fr (4.8mm/5.5mm) 8mm 10mm 14Fr (4.8mm/5.5mm) 9mm 10mm 14Fr (4.8mm/5.5mm) 9mm 12mm 14Fr (4.8mm/5.5mm) 10mm 12mm 14Fr (4.8mm/5.5mm) 11mm 12mm 14Fr (4.8mm/5.5mm) 12mm 14mm 14Fr (4.8mm/5.5mm) 13mm 14mm 14Fr (4.8mm/5.5mm) 13mm 16mm 14Fr (4.8mm/5.5mm) 14mm 16mm 14Fr (4.8mm/5.5mm) 15mm 16mm 14Fr (4.8mm/5.5mm) 15mm 18mm 16Fr (5.6mm/6.2mm) 16mm 18mm 16Fr (5.6mm/6.2mm) 16mm 20mm 16Fr (5.6mm/6.2mm) 17mm 18mm 16Fr (5.6mm/6.2mm) 17mm 20mm 16Fr (5.6mm/6.2mm) 18mm 20mm 16Fr (5.6mm/6.2mm) 18mm 22mm 16Fr (5.6mm/6.2mm) 19mm 22mm 16Fr (5.6mm/6.2mm) 19mm 24mm 16Fr (5.6mm/6.2mm) 20mm 24mm 16Fr (5.6mm/6.2mm) 21mm 24mm 16Fr (5.6mm/6.2mm)

Intended Aortic Vessel Diameter

Main Body Diameter

Introducer Sheath French Size (I.D. / O.D.)

Intended Iliac Vessel Diameter

Ipsi lateral Fenestrated Leg


Intended Iliac Vessel Diameter

Iliac Leg Diameter


16

11. INSTRUCTIONS FOR USE

GENERAL USE INFORMATION

PriortouseoftheZenith®FenestratedAAAEndovascularGraftwiththeH&L-BOne-Shot™IntroductionSystem,reviewthisSuggestedInstructionsforUsebooklet.Thefollowinginstructionsembodyabasicguidelinefordeviceplacement.Variationsinthefollowingproceduresmaybenecessary.These instructions are intended to help guide the physician and do not take the place of physicianjudgment.

PRE-IMPLANT DETERMINANTS

Verifyfrompre-implantplanningthatthecorrectdevicehasbeenselected.Determinantsinclude:1.Femoralarteryselectionforintroductionofthemainbodysystem,(i.e.,definerespectivecontralateral

andipsilateraliliacarteries).2. Angulationofaorticneck,aneurysmandiliacs.�.Qualityoftheaorticneck.4.Diametersofinfrarenalaorticneckanddistaliliacvessels.5.Distancefromrenalarteriestotheaorticbifurcation.6.Distancefromtherenalarteriestothehypogastric(internaliliac)arteries/attachmentsite(s).7.Aneurysm(s)extendingintotheiliacarteriesmayrequirespecialconsiderationinselectingasuitable

graft/arteryinterfacesite.8.Considerthedegreeofvascularcalcification.NOTE:Eachrespectivevesseldiameterandlength(aorta,ipsilateraliliacandcontralateraliliac)providesthenecessarycriteriaforchoosingtheappropriateendovasculargraft.

PATIENT PREPARATION

1.Refertoinstitutionalprotocolsrelatingtoanesthesia,anticoagulationandmonitoringofvitalsigns.2.Position patient on imaging table allowing fluoroscopic visualisation from the aortic arch to the

femoralbifurcations.�.Exposebothcommonfemoralarteriesusingstandardsurgicaltechnique.4.Establishadequateproximalanddistalvascularcontrolofbothfemoralvessels.

11.1 Fenestrated System

11.1.1 Proximal Body Graft Preparation/Flush 1.Removeblack-hubbedshippingstylet (fromthe innercannula),cannulaprotector tube(fromthe

innercannula)anddilatortipprotector(fromthedilatortip).RemovePeel-Away®sheathfrombackofthehemostaticvalve.(Figure 8)

Elevate distal tip of system and flush through the stopcock on the hemostatic valve until fluidemerges from the sideportnear the tipof the introduction sheath.(Figure 9)Continue to injecta full 20 ccof flushing solution through thedevice.Discontinue injectionandclose stopcockonconnectingtube.

NOTE:GraftflushingsolutionofHeparinisedsalineisoftenused.2.AttachsyringewithnormalHeparinisedsalinetothehubontheinnercannula.Flushuntilfluidexits

thedistaltip.(Figure 10)

Figure 8. Figure 9.

17

NOTE:Whenflushingsystem,elevatedistalendofsystemtofacilitateremovalofair.

11.1.2 Distal Bifurcated Body Graft Preparation/Flush 1.Removeblack-hubbedshippingstylet (fromthe innercannula),cannulaprotector tube(fromthe

innercannula)anddilatortipprotector(fromthedilatortip).RemovePeel-Away®sheathfrombackofthehemostaticvalve.(Figure 11)

Elevate distal tip of system and flush through the stopcock on the hemostatic valve until fluidemergesfromthesideportnearthetipoftheintroductionsheath.(Figure 12)Continuetoinjecta full 20 ccof flushing solution through thedevice.Discontinue injectionandclose stopcockonconnectingtube.

2.AttachsyringewithnormalHeparinisedsalinetothehubontheinnercannula.Flushuntilfluidexitsthedistaltip. (Figure 10)

11.1.3 Iliac Leg (Contralateral) Preparation/Flush1.Removeblack-hubbedinnerstylet(fromtheinnercannula),cannulaprotectortube(fromtheinner

cannula)anddilatortipprotector(fromthedilatortip).RemovePeel-Away®sheathfrombackofthehemostaticvalve.(Figure 1�)

Elevate distal tip of system and flush through the stopcock on the hemostatic valve until fluidemergesfromthesideportnearthetipoftheintroductionsheath.(Figure 14)Continuetoinjecta full 20 ccof flushing solution through thedevice.Discontinue injectionandclose stopcockonconnectingtube.

NOTE:GraftflushingsolutionofHeparinisedsalineisoftenused.2.AttachsyringewithHeparinisedsalinetothehubonthedistalinnercannula.Flushuntilfluidexits

thedistaldilatortip.(Figure 15)NOTE:Whenflushingsystem,elevatedistalendofsystemtofacilitateremovalofair.

Figure 11. Figure 10.

Figure 1�. Figure 12.


18

11.1.4 Vascular Access and Angiography 1.Puncturetheselectedcommonfemoralarteriesusingstandardtechniquewithan18or19UTgage

arterialneedle.Uponvesselentry,insert:•Wireguides-standard.035inch(0.89mm)diameter,145cmlong,JtiporBentsonWireGuide•Appropriatesizesheaths(e.g.,6French(2.0mmI.D.)or8French(2.7mmI.D.))•Flushcatheter(oftenradiopaquesizingcatheters-e.g.,CentimeterSizingCatheterorstraightflush

catheter)2.Performangiographytoidentifylevel(s)ofrenals,aorticbifurcationandiliacbifurcations.NOTE: If fluoroscope angulation is used with an angulated neck it may be necessary to performangiogramsusingvariousprojections.NOTE: A previous planning exercise will have determined which side will be used to introduce theproximalanddistalbodies.

11.1.5Proximal Body PlacementCAUTION: Verify that the predetermined access site is chosen for the introduction and placement of the proximal body. 1.EnsurethedeliverysystemhasbeenflushedwithHeparinisedsalineandthatallairisremovedfrom

thesystem.2.Give systemic heparin and check flushing solutions. Flush after each catheter and/or wire guide

exchange.NOTE:Monitorthepatient'scoagulationstatusthroughouttheprocedure.�.Onipsilateralside,replaceJwirewithstiffwireguide(AUSorLES).035inch(0.89mm),260cm

longandadvancethroughcatheteranduptothethoracicaorta.Removeflushcatheterandsheath.Maintainwireguideposition.

NOTE:Astraightangiographiccathetermaybeinsertedupthecontralateralsidetoaidinplacementofgraft.4.Beforeinsertion,positionproximalbodydeliverysystemonpatient'sabdomenunderfluoroscopyto

assistwithorientationandpositioning.Rotatetoapositionwheretheanteriormarkersaresituatedinthemostanterior(12:00o'clock)position.Thesidearmofthehemostaticvalvemayserveasanexternalreferencetothefenestration(s)and/orscallop(s),anteriorandposteriormarkersandbodysidemarkers.

CAUTION: Maintain wire guide position during delivery system insertions.CAUTION: To avoid any twist in the endovascular graft, during any rotation of the delivery system, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).5.Advance the delivery system until the radiopaque markers indicating the fenestration(s) and/or

scallop(s)areatthe leveloftheappropriatearteries.Checkthatthedistalendofthegraft is inasatisfactorypositionabovetheaorticbifurcationandthattheanteriorandposteriormarkersindicatethatthegraftisinsatisfactoryorientation. (Figure 16)

6.The‘tick’markercanbeusedtoassistwithorientationofthegraftduringdeploymentandprevent180-degreemis-orientationofthegraft.

•A marker formation of ( ) indicates an anterior position of the anterior markers. (Figure 16, Illustration A)

•A marker formation of ( ) indicates a posterior position of the anterior markers. (Figure 16, Illustration B)

NOTE: Angiography should be performed as needed throughout deployment, to confirm correctplacementofthegraft.

Figure 16.

Top ViewCross-Section

A. Anterior position of anterior markers.

B. Posterior position of anterior markers.

Figure 16a.

FluoroscopicImage

Anterior markers

Posterior markers

FluoroscopicImage

19

7.Verifypositionof thewireguide in the thoracic aorta. Ensure that fenestration(s) and/or scallopsare at the level of the appropriate arteries and the anterior markers are in the most anterior(12:00o'clock)position.

NOTE:Theverticalanteriormarkers,andthehorizontalposteriormarkersshouldformacross,onthefluoroscopicimage,whencorrectlyoriented.(Figure 16a) NOTE:The fenestration/scallopmarkers shouldbe incloseapposition to theappropriatesidebranchvessels.NOTE:EnsuretheCaptor™HemostaticValveontheintroducersheathisturnedtotheopenposition.(Figure 17)Clear identification of fenestration position(s) may not be possible until the graft has been fullyunsheathed.

8.Stabilisethegreypositioner(theshaftofthedeliverysystem)whilewithdrawingthesheath.Deploythefirsttwo(2)coveredstentsbywithdrawingthesheathwhilemonitoringdevicelocation.

9.Performangiography, andadjustgraftplacement asnecessary.Continue towithdraw the sheathmakingpositionaladjustmentsasnecessary.

NOTE: Techniques to ensure that the fenestration(s) and/or scallop(s) will accurately align withtheir respective vessels will vary, and will depend upon vessel anatomy, graft design, and physicianpreferences.10.Proceedwithdeploymentuntilthegrafthasbeenfullyunsheathed.(Figure 18)11.Whenasatisfactorygraftpositionhasbeenachieved,withdrawtheangiographiccatheterandwire

guide,thenexchangetoselectivewireguide/selectivecathetertobelowtheleveloftheproximalbody.Cannulatethepartiallydeployedproximalmainbody.

NOTE: Ifasmall fenestration isbeingutilised,careshouldbetakentoproperlyalignthefenestrationwiththerespectivevessel.12.Utilisingcontralateral access sheathandwireguide, advanceaguidingcatheter intoeach small

fenestrationanditsrespectivevessel.(Figure 19)NOTE:Non-compliantangioplastyballoonsmaybeusedasanalternativetoguidingcatheters.NOTE: Cannulation of the scallop and its respective vessel may also be achieved using similartechniques.NOTE: It isnot recommendedtouseballoonsorguidingcatheters toguide finalplacementof largefenestrationsasstentstrutsacrossfenestrationmayinterfere.1�.Verifyproperpositionofproximalbody.Removethesafetylockfromthegoldtrigger-wirerelease

mechanism. Withdraw and remove the trigger-wire by sliding the gold trigger-wire releasemechanismoffthehandleandthenremoveviaitsslotovertheinnercannula.(Figure 20)

NOTE: Atthispoint,theproximalmainbodygraftshouldbefullyexpandedwiththeproximalbarestentcontainedwithinthetopcap.


Figure 20.Figure 19.

20

14. Removethesafetylockfromtheblacktrigger-wirereleasemechanism.Withdrawandremovethetrigger-wiretounlockthesuprarenalstentfromthetopcapbyslidingtheblacktrigger-wirereleasemechanismoffthehandleandthenremoveviaitsslotovertheinnercannula.(Figure 21)

NOTE: The distal stent is still secured by the trigger-wire. 15. Loosenthepinvise.(Figure 22)Controlthepositionofthegraftbystabilizingthegreypositioner

oftheintroducer.CAUTION: Before deployment of suprarenal stent, verify that the position of the access wire extends just distal to the aortic arch.

16.Deploythesuprarenalstentbyadvancingthetopcap innercannula1to2mmatatimewhilecontrollingthepositionoftheproximalbodyuntilthetopstentisfullydeployed.(Figures 2�a and 2�b)Advancethetopcapcannulaanadditional1to2cmandthenretightenthepinvisetoavoidcontactwiththedeployedsuprarenalstent.

WARNING: The Zenith® Fenestrated AAA Endovascular Graft incorporates a suprarenal stent with fixation barbs. Exercise extreme caution when manipulating interventional devices in the region of the suprarenal stent.

17.Removethesafetylockfromthewhitetrigger-wirereleasemechanism.Withdrawandremovethetrigger-wiretodetachthedistalendoftheendovasculargraftfromthedeliverysystembyslidingthewhitetrigger-wirereleasemechanismoffthehandleandthenremoveviaitsslotoverthedeviceinnercannula.(Figure 24)

NOTE: Check to make sure that all trigger-wires are removed prior to withdrawal of the deliverysystem.

11.1.6 Docking of Top Cap1. Loosenthepinvise.(Figure 25)2.Securesheathandinnercannulatoavoidanymovementofthesecomponents.�.Advancethegreypositionerovertheinnercannulauntilitdockswiththetopcap.(Figures 26a, 26b

and 26c)NOTE:Ifresistanceoccurs,slightlyrotategreypositionerandcontinuetogentlyadvance.


Figure 2�a. Figure 2�b.

21

4.Retightenthepinviseandwithdrawtheentiretopcapandgreypositionerthroughthegraftandthroughthesheathbypullingontheinnercannula.(Figure 27)Leavethesheathandwireguideinplace.

24


Figure 26a.

26b

Figure 26b.

Figure 26c. Figure 27.

22

11.1.7 Fenestration Stent Placement and Deployment

GENERAL USE INFORMATION

In the event that small fenestrations are being utilized, stents may be placed to secure positivealignment.Standardtechniquesforplacementofarterialstentsshouldbeemployedduringuseofstents.1.Returntotheguidecatheterandwireguidewhichcannulatethesmallfenestrationandrespective

vessel.2. Introduceappropriatelysizedballoonexpandablestentandadvancetotheostiumofthefenestration/

vessel.Advanceintothevessel,leavingapproximately5mmofstentintheaorta.(Figure 28)NOTE:Fluoroscopicviewstangentialtothefenestrationwilloptimisevisualisationofthestentpositionrelativetothestentgraft.

�. Expandstent.4.Removetheballoonandreplacewithanoversizedangioplastyballoon.Advancetheballoonuntil

theproximaltipispositionedattheostium.5. Inflatetheballoontoflaretheintra-aorticsegmentofthestent.(Figure 29)CAUTION: This technique requires high quality imaging. Mobile image intensifiers provide less than adequate imaging quality.6. Removetheangioplastyballoon.NOTE: In the event that there is more than one fenestration, repeat the preceding steps for eachadditionalsmallfenestration.

11.1.8 Distal Bifurcated Body Placement1.Ensurethedeliverysystemhasbeenflushedwithheparnizedsalineandthatallairisremovedfrom

thesystem.2.Give systemic heparin and check flushing solutions. Flush after each catheter and/or wire guide

exchange.�. Before insertion, position distal bifurcated body delivery system on patient's abdomen under

fluoroscopytodeterminetheorientationofthecontralaterallimb.Thesidearmofthehemostaticvalvemayserveasanexternalreferencetothecontralaterallimbradiopaquemarker.

NOTE: Distal bifurcated body delivery system will not pass through the sheath used to deliver theproximalbody.NOTE:Theproximalbodydeliverysheathmustberemovedpriorto insertionofthedistalbifurcatedbodydeliverysystem.4. InsertDistalBifurcatedBodydeliverysystemoverthewire,intothefemoralarterywithattentionto

sidearmreference.CAUTION: Maintain wire guide position during delivery system insertion.CAUTION: To avoid any twist in the endovascular graft, during any rotation of the delivery, be careful to rotate all of the components of the system together (from outer sheath to inner cannula).5.Advancedeliverysystemuntilthecontralaterallimbispositionedaboveandanteriortotheoriginof

thecontralateraliliac.(Figure �0)Ifthecontralaterallimbradiopaquemarkerisnotproperlyaligned,rotate theentire systemuntil it iscorrectlypositionedhalfwaybetweena lateralandananteriorpositiononthecontralateralside.


2�

6. Repeatangiogramtoverify: •Thedegreeofoverlapwithproximalbody(nolessthan2stents) •Thepositionofthecontralaterallimb •Thepositionoftheipsilateraliliaccuffwithrespecttothecommoniliacbifurcation.Repositiondistalbifurcatedbodyasrequired.CAUTION: When introducing distal bifurcated body, observe proximal body closely to avoid any disruption to its position.NOTE:EnsuretheCaptor™HemostaticValveontheintroducersheathisturnedtotheopenposition.(Figure 17)7.Stabilisethegreypositioner(theshaftofthedeliverysystem)whilewithdrawingthesheath.Deploy

thefirsttwo(2)coveredstentsbywithdrawingthesheathwhilemonitoringdevicelocation.Proceedwithdeploymentuntilcontralaterallimbisfullydeployed.(Figure �1)

NOTE:Tickmarkeronthecontralaterallimbofthedistalbifurcatedbodyisusedtodetermineanterior/posteriororientationofthecontralaterallimb.Itisnotintendedtolineupwiththeanteriortickmarkontheproximalbody.

11.1.9 Contralateral Iliac Wire Guide Placement1.Advancethecontralateralcatheterandwireguideintothecommoniliacarterytoalevelbelowthe

shortcontralaterallimbandthenmanipulatethewireguideintothecontralaterallimbandintotheDistalBifurcatedBody.(Figure �2)APandobliquefluoroscopicviewscanaidinverificationofdevicecannulation.

2.Advance the angiographic catheter into the body of the graft. Perform angiography to confirmcorrectpositioninsidetheDistalBifurcatedBody.AdvancethecathetertowheretheproximalendoftheDistalBifurcatedBodyisattachedtotheintroducer.

30

Figure �0. Figure �1.

33

Figure �2. Figure ��.

24

11.1.10Distal Bifurcated Body Deployment1.Perform angiography to confirm proper position of the iliac leg with respect to the internal iliac

(hypogastric)artery.Adjustpositionifnecessary.2.Withdrawsheathuntiltheiliaclegisfullydeployed.�.Removethesafety lockfromtheblacktrigger-wirereleasemechanism.Withdrawandremovethe

trigger-wirebyslidingtheblacktrigger-wirereleasemechanismoffthehandleandthenremoveviaitsslotoverthedeviceinnercannula.(Figure ��)Stopwithdrawingsheath.

11.1.11Iliac Leg (Contralateral) Placement 1.Position the image intensifier to showboth thecontralateral internal iliacarteryandcontralateral

commoniliacartery.2.Prior to the introduction of the contralateral limb delivery system, inject contrast through the

contralateralfemoralsheathtolocatethecontralateralinternaliliacartery.�. Introduce the contralateral iliac legdelivery system into the artery. Advance slowly until the iliac

leg graft overlaps at least one full iliac leg stent (i.e., proximal stent of iliac leg graft) inside thecontralateral limbof themainbody.(Figure �4) If there isany tendency for thedistalbifurcatedbodygrafttomoveduringthismaneuver,holditinpositionbystabilizingthegreypositioneronthedistalbifurcatedbodycomponent(ontheipsilateralside).

NOTE:Ifdifficultyisencounteredadvancingtheiliaclegdeliverysystem,exchangetoamoresupportivewireguide.Intortuousvesselstheanatomymayaltersignificantlywiththeintroductionoftherigidwiresandsheathsystems.4.Confirmpositionofdistalendoftheiliacleggraft.Repositiontheiliacleggraftifnecessarytoensure

bothinternaliliacpatencyandaminimumoverlapofonefulliliaclegstent(i.e.,proximalstentofiliacleggraft,maximumoverlapof1.5stents)withinthemainbodyendovasculargraft.

5.Todeploy,holdtheiliacleggraftinpositionwiththegreypositionerwhilewithdrawingthesheath.(Figures �5a and �5b)

Ensureonestentoverlapismaintained.6.Stopwithdrawingthesheathassoonasthedistalendoftheiliacleggraftisreleased.7.Under fluoroscopy and after verification of iliac leg graft position, loosen pin vise, retract inner

cannulatodocktapereddilatortogreypositioner.Tightenpinvise.Maintainsheathpositionwhilewithdrawinggreypositionerwithsecuredinnercannula.(Figure �6)

8.Re-checkthepositionofthewireguide.

11.1.12Distal Bifurcated Body Deployment 1.Removethesafetylockfromthewhitetrigger-wirereleasemechanism.Withdrawandremovethe

trigger-wirebyslidingthewhitetrigger-wirereleasemechanismoffthehandleandthenremoveviaitsslotoverthedeviceinnercannula.(Figure �7)

2.Under fluoroscopy and after verification of iliac leg graft position, loosen pin vise, retract innercannulatodocktapereddilatortogreypositioner.Tightenpinvise.Maintainsheathpositionwhilewithdrawinggreypositionerwithsecuredinnercannula.

�.Re-checkthepositionofthewireguides.Leavesheathandwireguideinplace.4.Close theCaptor™HemostaticValveonthe introducer sheathby turning inaclockwisedirection

untilhemostasisisachieved.(Figure �8)

Figure �4. Figure �5a.

25

11.1.13Molding Balloon Insertion1.PrepareMoldingballoonasfollows: •FlushwirelumenwithHeparinisedsaline. •Removeallairfromballoon.

2. In preparation for the insertion of the molding balloon, open the Captor™ Hemostatic Valve byturningitcounter-clockwise.

�.AdvancetheMoldingballoonoverthewireguideandthroughtheHemostaticValveofthedistalbifurcatedbodyintroductionsystemtolevelofrenalarteries.Maintainpropersheathpositioning.

NOTE: Captor™HemostaticValvemaybeutilized to assistwithhemostasis by turning in a counter-clockwiserotationtothe“close”position.NOTE: Captor™ Hemostatic Valve should always be in the “open” position when repositioning ofmoldingballoon.4.Expandthemoldingballoonwithdilutedcontrastmedia(asdirectedbythemanufacturer) inthe

areaof thesuprarenal stentandthe infrarenalneck, startingproximallyandworking in thedistaldirection.(Figure �9)

CAUTION: Prior to molding in the vicinity of any Fenestration stent(s) confirm that the aortic section of the stent has been flared.CAUTION: Confirm complete deflation of balloon prior to repositioning.5.WithdrawtheMoldingballoontotheipsilaterallimbdistalfixationsiteandexpand.CAUTION: Do not inflate balloon in iliac vessel outside of graft.6.Deflateandremovemoldingballoon.Transferthemoldingballoonontothecontralateralwireguide

andintothecontralateraliliaclegintroductionsystem.Advancemoldingballoontothecontralaterallimboverlapandexpand.

CAUTION: Confirm complete deflation of balloon prior to repositioning.

Figure �5b. Figure �6.

Figure �7. Figure �8.

26

7.Withdraw the molding balloon to the contralateral iliac leg/vessel distal fixation and expand.(Figure �9)

CAUTION: Do not inflate balloon in iliac vessel outside of graft. 8.Remove molding balloon and replace it with an angiographic catheter to perform completion

angiograms.9. Removeorreplaceallstiffwireguidestoallowiliacarteriestoresumetheirnaturalposition.

FINAL ANGIOGRAM

1.Position angiographic catheter just above the level of the renal arteries. Perform angiography toverifythattherenalarteriesarepatentandthattherearenoendoleaks.Verifypatencyof internaliliacarteries.

2.Confirmtherearenoendoleaksorkinksandverifypositionofproximalgoldradiopaquemarkers.Removethesheaths,wiresandcatheters.

NOTE:Ifendoleaksorotherproblemsareobserved,refertoSection1.6,AncillaryComponents.�.Repairvesselsandcloseinstandardsurgicalfashion.

12. IMAGING GUIDELINES AND POST-OPERATIVE FOLLOW-UP

12.1General The long-term performance and safety of endovascular grafts has not yet been established.Asaresult,life-long,regularfollow-upmustbeundertakeninallpatientstoassesstheongoingperformanceof the Zenith® Fenestrated AAA Endovascular Graft. Patients with specific clinical findings (e.g.,endoleaks,enlarginganeurysmsorchangesinthestructureorpositionoftheendovasculargraft)shouldreceiveadditionalfollow-up.Patientsshouldbecounseledontheimportanceofadheringtothefollow-upschedule,bothduringthefirstyearandatyearlyintervalsthereafter.Patientsshouldbetoldthatregularandconsistentfollow-upisacriticalpartofensuringtheongoingsafetyandeffectivenessofendovasculartreatmentofAAAs.Physiciansshouldevaluatepatientsonanindividualbasisandprescribetheir follow-uprelativetotheneedsandcircumstancesofeachindividualpatient.TherecommendedimagingscheduleispresentedinTable 12.1.Thisschedulecontinuestobetheminimumrequirementforpatientfollow-upandshouldbemaintainedevenintheabsenceofclinicalsymptoms(e.g.,pain,numbness,weakness).Patientswithspecificclinicalfindings(e.g.,endoleaks,enlarginganeurysmsorchangesinthestructureorpositionofthestentgraft)shouldreceivefollow-upatmorefrequentintervals.Annual imagingfollow-upshould includeabdominalradiographsandbothcontrastandnon-contrastCT examinations. If renal complications or other factors preclude the use of image contrast media,abdominalradiographs,non-contrastCTandduplexultrasoundmaybeused.•Thecombinationofcontrastandnon-contrastCTimagingprovidesinformationonaneurysmdiameter

change,endoleak,patency, tortuosity,progressivedisease, fixation lengthandothermorphologicalchanges.

•Theabdominalradiographsprovideinformationondeviceintegrity(separationbetweencomponents,stentfractureandbarbseparation).

•Duplex ultrasound imaging may provide information on aneurysm diameter change, endoleak,patency, tortuosity and progressive disease. In this circumstance, a non-contrast CT should beperformedtouseinconjunctionwiththeultrasound.UltrasoundmaybealessreliableandsensitivediagnosticmethodcomparedtoCT.Table 12.1liststheminimumrequirementsforimagingfollow-upforpatientswiththeZenith®FenestratedAAAEndovascularGraft.Patientsrequiringenhancedfollow-upshouldhaveinterimevaluations.

BALLOON EXP ANSION/GRAFTSEALING SITES

Figure �9.

BALLOON EXPANSION/GRAFT SEALING SITES

27

Table 12.1Recommended Imaging Schedule for Endograft Patients

CT (Contrast & Abdominal Angiogram non-contrast) Radiographs

Pre-procedure X1 X1

Procedural X

Pre-discharge(within7days) X2,3,4 X

1month X2,3,4 X

3month X2,4,5

6month X2,4 X

12month(annuallythereafter) X2,4 X

1Imaging should be performed within 6 months before the procedure.2Duplex ultrasound may be used for those patients experiencing renal failure or who are otherwise unable to undergo contrast enhanced CT scan. With ultrasound, non-contrast CT is still recommended.�Either pre-discharge or 1 month CT recommended.4If Type I or III endoleak, prompt intervention and additional follow-up post-intervention recommended, see Section 12.6, Additional Surveillance and Treatment.5Recommended if endoleak reported at pre-discharge or 1 month.

12.2 Contrast and Non-Contrast CT Recommendations•Film sets should includeall sequential images at lowestpossible slice thickness<3mm).DoNOT

perform largeslice thickness (>3mm)and/oromitconsecutiveCT images/filmsets,as itpreventspreciseanatomicalanddevicecomparisonsovertime.

•Allimagesshouldincludeascaleforeachfilm/image.Imagesshouldbearrangednosmallerthan20:1imageson14inchx17inchsheetsiffilmisused.

•Bothnon-contrastandcontrastrunsarerequired,withmatchingorcorrespondingtablepositions.•Pre-contrastandcontrastrunslicethicknessandintervalmustmatch.•DONOTchangepatientorientationorre-landmarkpatientbetweennon-contrastandcontrastruns.Non-contrastandcontrastenhancedbaselineandfollow-upimagingareimportantforoptimalpatientsurveillance. It is important to followacceptable imagingprotocolsduring theCTexam. Table 12.2 (below)listsexamplesofacceptableimagingprotocols.

Table 12.2Acceptable Imaging Protocols

Non-Contrast Contrast

IVcontrast No Yes

Acceptablemachines Spiralcapableof>40seconds Spiralcapableof>40seconds

Injectionvolume n/a 150cc

Injectionrate n/a >2.5cc/sec

Injectionmode n/a Power

Bolustiming n/a Testbolus:SmartPrep,

C.A.R.E.orequivalent

Coverage-start Diaphragm 1cmsuperiortoceliacaxis

Coverage-finish Proximalfemur Profundafemorisorigin

Collimation <3mm <3mm

Reconstruction 2.5mmthroughout- 2.5mmthroughout-

softalgorithm softalgorithm

AxialDFOV 32cm 32cm

Post-injectionruns None None

28

12.3Abdominal RadiographsThefollowingviewsarerequired:•Fourfilms:supine-frontal(AP),cross-tablelateral,30degreeLPOand30degreeRPOviewscentered

onumbilicus.•Recordthetable-to-filmdistanceandusethesamedistanceateachsubsequentexamination.Ensureentiredeviceiscapturedoneachsingleimageformatlengthwise.If there is any concern about the device integrity (e.g., kinking, stent breaks, barb separation, relative component migration), it is recommended to use magnified views. The attending physician should evaluate films for device integrity (entire device length including components) using 2-4X magnification visual aid.

12.4 UltrasoundUltrasoundimagingmaybeperformedinplaceofcontrastCTwhenpatientfactorsprecludetheuseofimagecontrastmedia.Ultrasoundmaybepairedwithnon-contrastCT.Acompleteaorticduplexistobevideotapedformaximumaneurysmdiameter,endoleaks,stentpatencyandstenosis.Includedonthevideotapeshouldbethefollowinginformationasoutlinedbelow:•Transverse and longitudinal imaging should be obtained from the level of the proximal aorta

demonstrating mesenteric and renal arteries to the iliac bifurcations to determine if endoleaks arepresentutilizingcolorflowandcolorpowerangiography(ifaccessible).

•Spectralanalysisconfirmationshouldbeperformedforanysuspectedendoleaks.•Transverseandlongitudinalimagingofthemaximumaneurysmshouldbeobtained.

12.5 MRI Safety and Compatibility•TheMRsafetyandcompatibilityoftheZenith®AAAEndovascularGrafthasbeenevaluatedthrough

benchtestinginMRIsystemswithstaticfieldsof1.5Tesla,gradientmagneticfieldsof20Tesla/secondandwholebodyaveragedspecificabsorptionrate(SAR)of1.2W/kgfor30minutesofimaging.TheZenith®AAAEndovascularGraftwasfoundtoexhibitsignificantdeflectionandtorqueofthestainlesssteelmetalliccomponentof theendovasculargraftandthereforedidnotmeetstandard ‘MRISafe’benchtestcriteria.

•Adverse events have not been reported clinically in patients who have undergone MRI. However,sufficientdataarenotavailabletodemonstrateMRIsafetyandtheremaybepotentialrisks(e.g.,devicemigration,vesseldamage)thatcouldbeassociatedwithforcesappliedtothemetalliccomponentsoftheZenith®AAAEndovascularGraft.Therefore,acarefulassessmentofthesepotentialrisksandthepotentialbenefitstothepatientshouldbecompletedpriortouseofMRI imaging. Inaddition,thefacilityforMRIshouldbeappropriatelyselectedtoallowforpromptinterventionifnecessary.

•TheZenith®AAAEndovascularGraftmayaffectimagequality(imageartifact)dependingonthepulsesequencethatisusedforMRimaging.

NOTE:MRIlabellingprimarilybaseduponclinicalexperienceandbenchtestingwiththeZenith®AAAEndovascularGraftwhichismadefromstentsofthesamemetal.

12.6Additional Surveillance and TreatmentAdditionalsurveillanceandpossibletreatmentisrecommendedfor:•AneurysmswithTypeIendoleak•AneurysmswithTypeIIIendoleak•Aneurysmenlargement,5mmofmaximumdiameter(regardlessofendoleakstatus)•Migration• InadequateseallengthConsiderationforreinterventionorconversiontoopenrepairshouldincludetheattendingphysician'sassessmentofanindividualpatient'sco-morbidities,lifeexpectancyandthepatient'spersonalchoices.Patientsshouldbecounseledthatsubsequentreinterventionsincludingcatheterbasedandopensurgicalconversionarepossiblefollowingendograftplacement.

NOTES

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