Mri Safety Information - NuMED CP STENT Mode D'emploi

Cardiac catheterization carries certain risks. In addition, potential complications, and related adverse effects
associated with implants include, but are not limited to:
• Femoral artery injury, thrombosis or
psuedoaneurysm
• Stent Migration
• Stent Fracture
• Aortic Rupture/Tear
• Hematoma
• Thrombosis/Thromboembolism
• Death
• Endocarditis

MRI SAFETY INFORMATION

Nonclinical testing and modeling has demonstrated that the CP Stent is MR Conditional. A patient with this
device can be safely scanned in an MR system meeting the following conditions:
• Static magnetic field of 1.5 T and 3 T
• Maximum spatial gradient magnetic field of 2500 gauss/cm (25 T/m)
• Maximum MR system reported, whole body averaged specific absorption rate (SAR) of 2.0 W/kg for
15 minutes of scanning (Normal Operating Mode)
Based on nonclinical testing and modeling, under the scan conditions defined above, the CP Stent is expected
to produce a maximum in vivo temperature rise of less than 2°C after 15 minutes of continuous scanning.
MR image quality may be compromised if the area of interest is in the same area, or relatively close to the
position of the device. In nonclinical testing, the image artifact caused by the device extends approximately
3 mm from the CP Stent when imaged with a spin echo pulse sequence and 6 mm when imaged with a gradient
echo pulse sequence and a 3 T MRI System. The lumen of the device was obscured.
The presence of other implants or medical circumstances of the patient may require lower limits on some or all
of the above parameters.
Warning: Radiofrequency heating during MRI scans on overlapped, 10 zig CP Stents has not been evaluated.
INSTRUCTIONS FOR USE
Select Stent Size
1. Measure the length of the target stricture to determine the length of stent required. Size the stent length to
extend slightly proximal and distal to the stricture.
2. The appropriate stent length should be selected based on covering the entire obstructed segment with a
single stent.
Note: Should more than one stent be required, place the stent most distal from the puncture site first,
followed by placement of the proximal stent in tandem.
3. Measure the diameter of the reference stricture and vessel proximal and distal to the target lesion to
determine the appropriate size stent and delivery system.
Preparation of Stent
• Remove the stent from the packaging vial.
Preparation of Stent Delivery Catheter
• See instruction for use provided with the recommended balloon catheter.
Preparation of Stent Delivery System
1. Always place an appropriate sized guidewire through the balloon catheter lumen while prepping the balloon
and crimping the stent.
2. Remove the balloon protector and visually inspect the balloon being used to ensure that it is properly folded
to its lowest profile in preparation for the stent. "Dry Prepping" the balloon delivery catheter by using negative
pressure is highly recommended.
3. Slide the stent over the distal end of the balloon, maintaining the balloon fold, until the radiopaque markers
are equal distance from the ends of the stent. Check the stent position under the fluoroscope before
crimping.
4. Gently crimp (see insert IFU-CPCE) the stent on the balloon by using finger pressure and a "rolling action" to
exert equal pressure on all sides of the stent. Only crimp until no movement is felt on the catheter. Platinum is
very malleable and should be easily crimped. Place a small amount of undiluted contrast to "coat" the stent
and improve adherence to the balloon. (AVOID BENDING OR TWISTING THE STENT).
5. Visually inspect the balloon/stent assembly to assure proper placement of the stent and to assure that the
stent is evenly crimped. Uneven crimping could cause the stent to deploy in a non-symmetrical manner
(MAY BE CONFIRMED BY FLUOROSCOPY).
• Cell necrosis at the site of implant
• Stent Stenosis
• Aortic Aneurysm/Pseudoaneurysm
• Stent Malposition
• Sepsis/infection
• AV fistula formation
• Transitory arrhythmia
• Bleeding
• Cerebrovascular Incident
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