Potential adverse events that may occur following BARD ® E-LUMINEXX ® Vascular Stent implantation include, but are not limited to:
• Abrupt stent closure
• Allergic reaction to nitinol
• Amputation
• Aneurysm
• Angina/coronary ischemia
• Arterial aneurysm
• Arterial occlusion/thrombus, near the puncture site
• Arterial occlusion/thrombus, remote from puncture site
• Arterial occlusion/restenosis of the treated vessel
• Arterial rupture
• Arteriovenous fistula
• Arrhythmia
• Atheroembolization
• Death related to procedure
• Death unrelated to procedure
• Embolization, arterial
• Embolization, stent
• Fever
• Hematoma bleed, remote site
• Hematoma bleed at needle, device path: nonvascular procedure
• Hematoma bleed, puncture site: vascular procedure
• Hypersensitivity reactions
• Hypotension/hypertension
• Intimal injury/dissection
• Ischemia/infarction of tissue/organ
• Ischemia requiring intervention (bypass or amputation of toe, foot or leg)
• Local infection
• Malposition (failure to deliver the stent to the intended site)
• Myocardial infarction
• Pseudoaneurysm formation
• Pulmonary embolism
• Renal failure
• Restenosis of the stented artery
• Septicemia/bacteremia
• Stent malapposition
• Stent migration
• Stent strut fracture
• Stroke
• Vasospasm
• Worsened claudication/rest pain
• Tissue necrosis
• Venous occlusion/thrombus, remote from puncture site
• Venous occlusion/thrombus, near the puncture site