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Endurant II AAA


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Endurant II AAA - 1

Contraindications The Endurant II Stent Graft System is contraindicated in: • Patients who have a condition that threatens to infect the graft. • Patients with sensitivities or allergies to the device materials. Warnings and Precautions • he long-term safety and effectiveness of the Endurant II Stent Graft System has not T been established. All patients should be advised that endovascular treatment requires lifelong, regular follow-up to assess the health and the performance of the implanted endovascular stent graft. Patients with specific clinical findings (e.g., endoleaks, enlarging aneurysms or changes in the structure or position of the endovascular graft) should receive enhanced follow-up. Specific follow-up guidelines are described in the Instructions for Use. • atients experiencing reduced blood flow through the graft limb, aneurysm P expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures. • he Endurant II Stent Graft System is not recommended in patients unable to undergo T or who will not be compliant with the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use. • enal complications may occur: 1) From an excess use of contrast agents. R 2) As a result of emboli or a misplaced stent graft. The radiopaque marker along the edge of the stent graft should be aligned immediately below the lower-most renal arterial origin. • tudies indicate that the danger of micro-embolization increases with increased S duration of the procedure. • he safety and effectiveness of the Endurant II Stent Graft System has not been T evaluated in some patient populations. Please refer to the product Instructions for Use for details. Medtronic Vascular, Inc. 3576 Unocal Place Santa Rosa, CA 95403 USA Product Services Support Center Tel: 888.283.7868 Fax: 800.838.3103 CardioVascular LifeLine Customer Support Tel: 877.526.7890 Tel: 763.526.7890 MRI Safety and Compatibility Non-clinical testing has demonstrated that the Endurant II Stent Graft is MR Conditional. It can be scanned safely in both 1.5 T & 3.0 T MR systems under certain conditions as described in the product Instructions for Use. For additional information regarding MRI please refer to the product Instructions for Use. Adverse Events Potential adverse events include (arranged in alphabetical order): Amputation; Anesthetic complications and subsequent attendant problems (e.g. aspiration), Aneurysm enlargement; Aneurysm rupture and death; Aortic damage, including perforation, dissection, bleeding, rupture and death; Arterial or venous thrombosis and/or pseudoaneurysm; Arteriovenous fistula; Bleeding, hematoma or coagulopathy; Bowel complications (e.g., ileus, transient ischemia, infarction, necrosis); Cardiac complications and subsequent attendant problems (e.g. arrhythmia, myocardial infarction, congestive heart failure, hypotension, hypertension); Claudication (e.g., buttock, lower limb); Death; Edema; Embolization (micro and macro) with transient or permanent ischemia or infarction; Endoleak; Fever and localized inflammation; Genitourinary complications and subsequent attendant problems (e.g., ischemia, erosion, fistula, incontinence, hematuria, infection); Hepatic failure; Impotence; Infection of the aneurysm, device access site, including abscess formation, transient fever and pain; Lymphatic complications and subsequent attendant problems (e.g., lymph fistula); Neurologic local or systemic complications and subsequent attendant problems (e.g., confusion, stroke, transient ischemic attack, paraplegia, paraparesis, paralysis); Occlusion of device or native vessel; Pulmonary complications and subsequent attendant problems; Renal complications and subsequent attendant problems (e.g., artery occlusion, contrast toxicity, insufficiency, failure); Stent graft: improper component placement; incomplete component deployment; component migration; suture break; occlusion; infection; stent fracture; graft twisting and/or kinking; insertion and removal difficulties; graft material wear; dilatation; erosion; puncture and perigraft flow; Surgical conversion to open repair; Vascular access site complications, including infection, pain, hematoma, pseudoaneurysm, arteriovenous fistula, dissection; Vascular spasm or vascular trauma (e.g., iliofemoral vessel dissection, bleeding, rupture, death); Vessel damage; Wound complications and subsequent attendant problems (e.g., dehiscence, infection, hematoma, seroma, cellulitis) Please reference product Instructions for Use for more information regarding indications, warnings, precautions, contraindications and adverse events. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. UC201201590 EN © Medtronic, Inc. 2012. All Rights Reserved. Printed in the USA. For distribution in the USA only. 04/12 Indications The Endurant® II Stent Graft System is indicated for the endovascular treatment of infrarenal abdominal aortic or aorto-iliac aneurysms in patients with the following characteristics: • Adequate iliac/femoral access that is compatible with vascular access techniques, devices and/or accessories • Proximal neck length of ≥ 10 mm • Infrarenal neck angulation of ≤ 60° • Distal fixation length of ≥ 15 mm • Aortic neck diameters with a range of 19 to 32 mm • Iliac diameters with a range of 8 to 25 mm • Morphology suitable for aneurysm repair

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Endurant II AAA - 2

F R O M T H E E V E R Y D AY TO THE EXTR AORDINARY Endurant II extends the proven performance of Endurant with a lower profile,* additional limb lengths and enhanced visibility. With all the deliverability, conformability and range of its predecessor—and with even more options for clinical success—Endurant II empowers stronger results for more patients. Controlled release Low-profile, hydrophilic delivery system for enhanced access Single-piece, laser-cut nitinol stent with anchor pins for suprarenal fixation High-density, multifilament polyester graft material Longer limb lengths offer...

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