Important Safety Information Abdominal Aortic Aneurysm (AAA)
This therapy is not for everyone. Please consult your physician. A prescription is required. For more information, please call Medtronic at (800) 961-9055.
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:
The Endurant II Stent Graft System is contraindicated in:
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 1.5T & 3.0T 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.
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 (eg, 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.
Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.
The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.
The following complications may be associated with the use of guide wire devices; Air Embolism/Thromboembolism; Allergic Reactions; Amputation; Arteriovenous Fistula; Death; Embolism; Hematoma; Hemorrhage; Hemoglobinuria; Infection or Sepsis; Myocardial Ischemia and/or Infarction; Pseudoaneurysm; Stroke (CVA)/Transient Ischemic Attacks (TIA); Thrombus; Vessel Occlusion; Vessel Perforation, Dissection, Trauma, or Damage; Vessel Spasm; Wire Entrapment/Entanglement; and Foreign body/Wire Fracture.
This device is intended for use by physicians trained and experienced in diagnostic and interventional techniques.
CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a licensed healthcare practitioner. See package inserts for full product information. Please contact your local Medtronic sales representative for more information. For US distribution only.