Potential Adverse Events - COOK Medical Zilver Flex 35 Mode D'emploi

• Maximum MR system reported, whole-body-averaged specific absorption rate (SAR) of
2.9 W/kg for 15 minutes of scanning (i.e., per pulse sequence)
Non-clinical evaluation, including analysis of the effects of blood flow, was conducted for
single and two overlapped versions of the ZILVER FLEX™35 Vascular Stents (lengths = 140 and
200 mm) producing a maximum temperature change of 3.1°C during 15 minutes of MRI
performed at 1.5-Tesla (Magnetom, Siemens Medical Solutions, Malvern, PA) and 3-Tesla
(Excite, General Electric Healthcare, Milwaukee, WI) under the following minimum conditions:
140 mm and 200 mm lengths:
MR system reported, whole body averaged SAR
Calorimetry measured values, whole body averaged SAR 2.1-W/kg
Image Artifacts
MR image quality may be compromised if the area of interest is in the same area or within
approximately 5 mm of the position of the ZILVER FLEX™35 Vascular Stent, as found during
non-clinical testing using the sequence: T1-weighted, spin echo and gradient echo pulse
sequence in a 3.0 Tesla MR system (Excite, General Electric Healthcare, Milwaukee, WI).
Therefore, it may be necessary to optimize MR imaging parameters for the presence of this
metallic implant. Heating in the MRI environment for stents with fractured struts is not known.

POTENTIAL ADVERSE EVENTS

Potential adverse events that may occur include, but are not limited to:
• Abrupt stent closure
• Allergic reaction to nitinol
• Amputation
• Angina/coronary ischemia
• Arrhythmia
• Arterial aneurysm
• Arterial rupture
• Arteriovenenous fistula
• Atheroembolization (Blue Toe Syndrome)
• Death
• Embolism
• Fever
• Hematoma/hemorrhage
• Hypersensitivity reactions
• Hypotension/hypertension
• Infection/abscess formation at access site
• Intimal injury/dissection
• Ischemia requiring intervention (bypass or amputation of toe, foot or leg)
• Myocardial infarction
• Pseudoaneurism formation
• Pulmonary embolism
• Renal failure
• Restenosis of the stented artery
• Septicemia/bacteraemia
• Stent malapposition
• Stent migration
• Stent strut fracture
• Stroke
1.5-Tesla
2.9-W/kg
11
3-Tesla
3.0-W/kg
2.8-W/kg