7
Post Implant
• Appropriate antiplatelet/anticoagulant therapy should be administered post procedure.
• Use caution when re-crossing a stent to avoid stent damage or migration.
MR CONDITIONAL
Non-clinical testing has demonstrated that the Zilver Vascular Stent is MR Conditional. It can
be scanned safely under the following conditions:
• Static magnetic field of 3 Tesla or less
• Spatial gradient field of 720 Gauss/cm or less
• Whole body averaged specific absorption rate (SAR) of 1.5 W/kg (for a single stent
at 1.5 Tesla) and 3 W/kg (for a single stent at 3 Tesla and a pair of overlapping stents
at 1.5 and 3 Tesla) for 20 minutes (for a single stent at 1.5 Tesla) and 15 minutes of
scanning (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla),
respectively.
In non-clinical testing, the Zilver Vascular Stent produced maximum temperature rises of
0.1, 3.8, 0.8, and 0.1 degrees C (for a single stent at 1.5 Tesla, a pair of overlapping stents at
1.5 Tesla, a single stent at 3 Tesla, and a pair of overlapping stents at 3 Tesla, respectively) at
whole body averaged specific absorption rates (SAR) of 1.5 W/kg (for a single stent at 1.5 Tesla)
and 3 W/kg (for a single stent at 3 Tesla and a pair of overlapping stents at 1.5 and 3 Tesla)
for 20 minutes (for a single stent at 1.5 Tesla) and 15 minutes (for a single stent at 3 Tesla and
a pair of overlapping stents at 1.5 and 3 Tesla) of MR scanning in a 1.5 Tesla/64 MHz General
Electric MR scanner, a 1.5 Tesla Magnetom Siemens Medical Solutions MR Scanner (to evaluate
a pair of overlapping stents), and a 3 Tesla Excite General Electric MR scanner.
MR image quality may be compromised if the area of interest is in the exact same area or
relatively close to the position of the Zilver Vascular Stent. 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, the following:
• Abrupt stent closure
• Allergic reaction to nitinol
• Amputation
• Angina/coronary ischemia
• Arrhythmia
• Arterial aneurysm
• Arterial rupture
• Arteriovenous fistula
• Atheroembolization (Blue Toe Syndrome)
• Death
• Embolism
• Fever
• Hematoma/hemorrhage
• Hypersensitivity reactions
• Hypotension/hypertension
• Infection/abscess formation at access site
• Intimal injury/dissection
Содержание Zilver
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