representative name physician’s signature the first · 2018. 3. 28. · bard peripheral vascular,...

SIMON NITINOL ® Vena Cava Filter Indications for Use: The Simon Nitinol ® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated. Contraindications for Use: The Simon Nitinol ® Filter should not be implanted in: • Pregnant patients when fluoroscopy may endanger the fetus • Patients with vena cava diameters greater than 28 mm • Patients with vena cava diameters greater than 24 mm if those patients are scheduled for surgery requiring general anathesia within two weeks • Patients with risk of septic embolism. Potential Complications: • Migration of the filter. This may be caused by placements in oversized venae cavae greater than 28mm, or larger migrating thrombus dislodging the filter from its deployed position. • Perforation of the vena cava wall by the legs of the filter. • Recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombus passed through the filter or via collateral means. • Caval occlusion. The probability of this occurring should be weighed against the inherent risk/benefit ratio for a patient who is experiencing pulmonary embolism, or who is likely to do so without intervention. Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use. Bard and Simon Nitinol are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners. Bard Peripheral Vascular, Inc. 1625 W. 3rd Street Tempe, AZ 85281 USA Tel: 1 480 894 9515 / 1 800 321 4254 Fax: 1 480 966 7062 / 1 800 440 5376 www.bardpv.com Simon Nitinol ® Filter Delivery Kit Ordering Information CONTACT PHONE NO. REPRESENTATIVE NAME PHYSICIAN’S SIGNATURE The First Product Code Description Sheath Length Quantity 2120F Femoral Delivery Kit 48 cm 1 ea 2220J Jugular/Subclavian Delivery Kit 83 cm 1 ea 2320A Antecubital Delivery Kit 103 cm 1 ea Individual Delivery Sheath/Dilator Sets for Simon Nitinol ® Filter Ordering Information Product Code Description Sheath Length Quantity 3120F Femoral Delivery Kit 48 cm 1 ea 3220J Jugular/Subclavian Delivery Kit 83 cm 1 ea 3320A Antecubital Delivery Kit 103 cm 1 ea Copyright © 2012, C. R. Bard, Inc. All Rights Reserved. S11494 Rev 2

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Page 1: REPRESENTATIVE NAME PHYSICIAN’S SIGNATURE The First · 2018. 3. 28. · Bard Peripheral Vascular, Inc. 1625 W. 3rd Street Tempe, AZ 85281 USA Tel: 1 480 894 9515 / 1 800 321 4254

Simon nitinol® Vena Cava FilterIndications for Use: The Simon Nitinol® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations: • Pulmonary thromboembolism when anticoagulants are contraindicated • Failure of anticoagulant therapy in thromboembolic disease • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed or is contraindicated.

Contraindications for Use: The Simon Nitinol® Filter should not be implanted in: • Pregnant patients when fluoroscopy may endanger the fetus • Patients with vena cava diameters greater than 28 mm • Patients with vena cava diameters greater than 24 mm if those patients are scheduled for surgery requiring general anathesia within two weeks • Patients with risk of septic embolism.

Potential Complications: • Migration of the filter. This may be caused by placements in oversized venae cavae greater than 28mm, or larger migrating thrombus dislodging the filter from its deployed position. • Perforation of the vena cava wall by the legs of the filter. • Recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombus passed through the filter or via collateral means. • Caval occlusion. The probability of this occurring should be weighed against the inherent risk/benefit ratio for a patient who is experiencing pulmonary embolism, or who is likely to do so without intervention.

Please consult product labels and package inserts for indications, contraindications, hazards, warnings, cautions and instructions for use.

Bard and Simon Nitinol are trademarks and/or registered trademarks of C. R. Bard, Inc., or an affiliate. All other trademarks are the property of their respective owners.

Bard Peripheral Vascular, Inc.1625 W. 3rd Street

Tempe, AZ 85281 USA

Tel: 1 480 894 9515 / 1 800 321 4254

Fax: 1 480 966 7062 / 1 800 440 5376

www.bardpv.com

Simon Nitinol® Filter Delivery Kit Ordering Information

CONTACT PHONE NO.

REPRESENTATIVE NAME

PHYSICIAN’S SIGNATURE

The First

Product Code Description Sheath Length Quantity

2120F Femoral Delivery Kit 48 cm 1 ea