Vascular Restorer CoCr Instructions D'utilisation page 5

therapies for living
- Positioning the stent in an important bifurcation may obstruct or hamper future access to lateral
branches.
- Immediately after an implant, if it were necessary to re-cross the stent, great care must be taken
not to push it with the guides or balloons so as not to dislodge it.
- Corrosion by friction of superimposed prosthesis has not been demonstrated.
Precautions: MRI Safety[1]:
Through non-clinical testing, security was proved by magnetic resonance (MR) imaging of L605 type
cobalt chromium stents under certain conditions (MR conditional). The conditions of the MR test used to
assess these devices were the following: for magnetic field interactions, a static magnetic field strength
of 3.0 Tesla, with a maximum spatial gradient of 720 gauss/cm; for MR-related heating, a maximum
whole body averaged specific absorption rate (SAR) of 1.54W/kg for 15 minutes in a 1.5-Tesla field and an
average specific absorption rate (SAR) of 2.8W/kg for 15 minutes in a 3.0-Tesla field. The temperature rise
for a stent was no higher than 0.8°C while for an overlapped pair it was no higher than 1.0°C.
No clinical or non-clinical testing has been conducted to rule out the possibility of stent migration at field
strengths of over 3.0 Tesla. It is not advisable to perform MR tests at strengths of over 3.0 Tesla until 7
days have elapsed following implantation.
MR imaging quality may be affected if the area of interest is adjacent or very close to the stent place.
6. Possible adverse effects/complications
The possible adverse effects and/or complications which could arise before, during or after the procedure
include the following:
- Death
- Infarction/angina
- Stroke / embolism / thrombosis
- Emergency bypass surgery
- Endocarditis
- Total occlusion of the artery / thrombosis / stent embolisation
- Perforation or dissection of the segment treated
- Gaseous embolism
- Arteriovenous fistula
- Renal failure
- Migration of endoprosthesis / bad positioning / partial deployment
- Allergic reaction to the metals or contrast media
- Reocclusion of the segment treated: restenosis
- Artery spasms
- Haemodynamic deterioration
- Arrhytmias
- Aneurysm or pseudoaneurysm
- Infections
- Hypotension/hypertension
- Local haemorrhage with haematoma at the insertion site
Specifically for biliary use
- Abscess
- Additional intervention due to, but not limited to:
• Endoprothesis migration
• Bad positioning
• Partial deployment
[1] These data have been obtained bibliographically, searching for market stents of equal composition. It is recommended that MRI is not
performed unless strictly necessary for the patient. If the patient can wait, it is better to perform the MRI when the stent has endothelialized,
around four weeks after implantation.
INSTRUCTIONS FOR USE
PERIPHERAL STENT SYSTEM CoCr
restorer
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