Important Safety Information
Abdominal Aortic Aneurysm (AAA)
This therapy is not for everyone. Please consult your physician.
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
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
- The long-term safety and effectiveness of the Endurant II Stent Graft System has not 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.
- Patients experiencing reduced blood flow through the graft limb, aneurysm expansion, and persistent endoleaks may be required to undergo secondary interventions or surgical procedures.
- The Endurant II Stent Graft System is not recommended in patients unable to undergo or who will not be compliant with the necessary preoperative and postoperative imaging and implantation studies as described in the Instructions for Use.
- Renal complications may occur: 1) From an excess use of contrast agents. 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.
- Studies indicate that the danger of micro-embolization increases with increased duration of the procedure.
- The safety and effectiveness of the Endurant II Stent Graft System has not been evaluated in some patient populations. Please refer to the product Instructions for Use for details.
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.
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 (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.
Important Information
Prior to use, refer to the Instructions for Use supplied with these devices for indications, contraindications, suggested procedure, warnings and precautions.
Indications for Use
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.
Potential Adverse Events
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.
Warnings and Precautions
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.