Mri Information - COOK Medical Evolution EVO-20-25-8-E Instructions For Use Manual

increase risk of stent migration due to tumor shrinkage, stent erosion,
and/or mucosal bleeding.
Long-term patency of this device has not been established. Periodic
evaluation is advised.
WARNINGS
The stent is not intended to be removed or repositioned after stent
placement and is considered a permanent implant. Attempts to remove
or reposition stent after placement may cause damage to surrounding
tissue or mucosa. Stent cannot be retrieved after the deployment
threshold has been passed. Corresponding marks on outer catheter and
delivery handle indicate when threshold has been passed.
This stent contains nickel, which may cause an allergic reaction in
individuals with nickel sensitivity.
To minimize pain and tenesmus, the stent end nearest to the anal canal/
anus should be placed 2 cm above the anal canal or 6 cm from the anus.
The device should be used with caution and only after careful
consideration in patients with:
• Patients with radiation colitis or proctitis.
• Patients with elevated bleeding times, coagulopathies.

MRI INFORMATION

This symbol means the device is MR Conditional.
Non-clinical testing has demonstrated that the Evolution®
Colonic Stent is MR Conditional according to ASTM
F2503. A patient with this stent can be scanned safely anytime after
placement under the following conditions
• Static magnetic field of 3.0 Tesla or less.
• Spatial magnetic gradient field of 720 Gauss/cm. Non-clinical
evaluation was conducted in a MR system (Excite, General Electric
Healthcare) with a maximum spatial magnetic gradient field of 720
Gauss/cm as measured with a gaussmeter in the position of the static
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