Arrhythmia Arterial occlusion / thrombosis at puncture site or remote site Arteriovenous fistula Bacteremia or septicemia Bleeding from • • • • anticoagulant or antiplatelet medications Cerebral edema Cerebral hemorrhage Cerebral ischemia / transient ischemic attack (TIA) • • • • Congestive heart failure (CHF) Death Detachment and / or implantation of a component of the system Emboli, distal (air, tissue or • • • thrombotic emboli) Emergent or urgent endarterectomy surgery (CEA) Fever Filter thrombosis / occlusion Groin hematoma, with or • • • • without surgical repair Hemorrhage, with or without transfusion Hyperperfusion syndrome Hypotension / hypertension Infection and pain • • • • at insertion site Ischemia / infarction of tissue / organ Myocardial infarction (MI) Pain (head, neck) Pseudoaneurysm, femoral Renal • • • • • failure / insufficiency Restenosis of stented segment Seizure Severe unilateral headache Stent / filter entanglement / damage Stent • • • • • embolization Stent malposition Stent migration Stent thrombosis / occlusion Stroke / cerebrovascular accident (CVA) Total occlusion of • • • • • carotid artery Vessel dissection, perforation, or rupture • Vessel spasm or recoil • Prior to use, please reference the Instructions for Use at www.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.
Arrhythmia • Arterial occlusion / thrombosis at puncture site or remote site • Arteriovenous fistula • Bacteremia or septicemia • Bleeding from anticoagulant or antiplatelet medications • Cerebral edema • Cerebral hemorrhage • Cerebral ischemia / transient ischemic attack (TIA) • Congestive heart failure (CHF) • Death • Detachment and / or implantation of a component of the system • Emboli, distal (air, tissue or thrombotic emboli) • Emergent or urgent endarterectomy surgery (CEA) • Fever • Filter thrombosis / occlusion • Groin hematoma, with or without surgical repair • Hemorrhage, with or without transfusion • Hyperperfusion syndrome • Hypotension / hypertension • Infection and pain at insertion site • Ischemia / infarction of tissue / organ • Myocardial infarction (MI) • Pain (head, neck) • Pseudoaneurysm, femoral • Renal failure / insufficiency • Restenosis of stented segment • Seizure • Severe unilateral headache • Stent / filter entanglement / damage • Stent embolization • Stent malposition • Stent migration • Stent thrombosis / occlusion • Stroke / cerebrovascular accident (CVA) • Total occlusion of carotid artery • Vessel dissection, perforation, or rupture • Vessel spasm or recoil Prior to use, please reference the Instructions for Use at www.abbottvascular.com for more information on indications, contraindications, warnings, precautions, and adverse events.
Sample%20HIGH%20RISK%20Letter%20of%20Medical%20Necessity%20(AP2938813-US%20Rev%20B).docx