Mri Safety Information - NuMED MOUNTED CP STENT CP8Z16 Mode D'emploi

• This device is intended for single use only. Do not resterilize and/or reuse it, as this can potentially result in
compromised device performance and increased risk of cross contamination.
PRECAUTIONS
• Use of an inflation device with pressure gauge is highly recommended during this procedure.
• Stents are delicate devices. Care should be exercised while handling to help prevent the possibility of
breakage.
• The stent is rigid and may make negotiation through vessels difficult.
• Dilatation procedures should be conducted under fluoroscopic guidance with appropriate x-ray equipment.
• Guidewires are delicate instruments. Care should be exercised while handling to help prevent the possibility
of breakage.
• Careful attention must be paid to the maintenance of tight catheter connections and by aspiration before
proceeding to avoid air introduction into the system.
• The inflation diameter of the balloon used during stent delivery should approximate the diameter of the
obstructive vessel and the intended implant site.
• Under no circumstances should any portion of the catheter system be advanced against resistance. The
cause of the resistance should be identified with fluoroscopy and action taken to remedy the problem.
• If resistance is felt upon removal, then the balloon, guidewire and the sheath should be removed together as
a unit, particularly if balloon rupture or leakage is known or suspected. This may be accomplished by firmly
grasping the balloon catheter and sheath as a unit and withdrawing both together, using a gentle twisting
motion combined with traction.
• The balloons must be completely deflated before retracting into the sheath.
• Proper functioning of the catheter depends on its integrity. Care should be used when handling the catheter.
Damage may result from kinking, stretching, or forceful wiping of the catheter.
POTENTIAL COMPLICATIONS/ADVERSE EFFECTS
NOTE: Circumferential tear of the delivery balloon catheter prior to complete expansion of the stent may cause
the balloon to become tethered to the stent, requiring surgical removal. In case of rupture of an adequately sized
balloon after stent expansion, it can be withdrawn and a new balloon catheter exchanged over a guidewire to
complete expansion of the stent.
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.
• 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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