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; EndoAnchor (for infrarenal EVAR procedures using the Heli-FX EndoAnchor system): partial deployment, inaccurate deployment, fracture, dislodgement, embolization, stent graft damage, modelling balloon damage); 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, femoral-femoral artery thrombosis, 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.
FTSOP113326-06 Rev. 1F