Potential Adverse Events - COOK Medical FORMULA 418 Gebrauchsanweisung

Image Artifact
MR image quality may be compromised if the area of interest is within the lumen or within approximately 15 mm
of the Formula 7 mm x 20 mm stent. Therefore, it may be necessary to optimize MR imaging parameters for the
presence of this metallic stent.
MedicAlert Foundation
Cook recommends that the patient register the MR conditions disclosed in this IFU with the MedicAlert Foundation.
The MedicAlert Foundation can be contacted at:
Mail: MedicAlert Foundation International
2323 Colorado Avenue
Turlock, CA 95382
Phone: +1-888-633-4298 (toll free)
+1-209-668-3333 (from outside the US)
Fax: +1-209-669-2450
Web: www.medicalert.org

POTENTIAL ADVERSE EVENTS

Adverse events that may be associated with the use of a vascular stent are presented in the following alphabetical list
and include, but are not limited to:
• Abscess
• Allergic reaction to stainless steel or contrast agents
• Arrhythmias (ventricular fibrillation, ventricular tachycardia, other)
• Arteriovenous fistula
• Bowel infarct
• Death
• Dialysis
• Dissection
• Drug reaction to antiplatelet agents
• Drug reaction, allergic reaction to contrast media
• Emboli (air, tissue, or thrombotic emboli) resulting in tissue ischemia/infarction
• Emergency surgery to correct vascular complications
• Emergent renal artery bypass surgery
• Extremity ischemia/amputation
• Fever
• Gastrointestinal symptoms from anticoagulation/antiplatelet medication
• Hematoma at vascular access site
• Hemorrhage requiring transfusion
• Hypersensitivity reactions
• Hypotension/hypertension
• Infection and pain at vascular access site
• Intimal tear
• Kidney infarct
• Myocardial infarction
• Myocardial ischemia
• Nephrectomy
• Peripheral neuropathy
• Pseudoaneurysm at vascular access site
• Pseudoaneurysm formation
• Renal artery thrombosis, aneurysm, rupture, perforation, occlusion, spasm, or restenosis
• Renal insufficiency or failure
• Stent migration or embolization
• Stent misplacement
• Stroke/cerebral vascular accident
• Tissue necrosis or ulceration
6