Bard COVERA PLUS Instructions For Use Manual page 5

MAGNETIC RESONANCE IMAGING MRI COMPATIBILITY
Non-clinical testing has demonstrated that the C
OVERA
a single covered stent in the vessels of the arm and placement of a single covered stent or overlapped covered stents in the
iliac and superficial femoral arteries for all clinically relevant lengths. Based upon the preclinical testing, patients with the
C ™ P
Vascular Covered Stent can be safely scanned, immediately after placement of this implant, under the following
OVERA LUS
conditions:
3.0 Tesla Temperature Rise
In an analysis based on non-clinical testing according to ASTM F2182-11a and computer modeling of a patient, the single
6 x 100 mm C ™ P
Vascular Covered Stent was determined to produce a potential worst-case temperature rise of less than
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3 °C at a whole body SAR of 1 W/kg for 15 minutes of MR scanning in a 3.0 Tesla, whole body MR system. Cooling due to blood
flow inside the covered stent and perfusion in the vascular bed surrounding the covered stent was included in the assessment of
in-vivo temperature rise.
1.5 Tesla Temperature Rise
In an analysis based on non-clinical testing according to ASTM F2182-11a and computer modeling of a patient, the single
6 x 100 mm C ™ P
OVERA LUS Vascular Covered Stent was determined to produce a potential worst-case temperature rise of less than
3 °C at the whole body SAR of 1 W/kg for 15 minutes of MR scanning in a 1.5 Tesla, whole body MR system. Cooling due to blood
flow inside the covered stent and perfusion in the vascular bed surrounding the covered stent was included in the assessment of
in-vivo temperature rise.
Image Artifact
Artifact tests were performed according to ASTM F2119-07. 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 covered stent. Maximum artifact extended 5.5 mm beyond the covered
stent for the spin echo sequence and 5.5 mm for the gradient echo sequence. The lumen was obscured.
Additional Information
Good clinical MR practice should be followed, including placement of padding between the bore wall and the patient and
avoiding contact between the hands and the body.
The C ™ P
Vascular Covered Stent has not been evaluated in MRI systems with field strengths other than 1.5 or 3.0 Tesla.
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The heating effect in the MRI environment for fractured covered stents is not known. The presence of other implants or the health
state of the patient may require reduction of the MRI limits listed above.
HOW SUPPLIED
The C ™ P
Vascular Covered Stent is supplied sterile (by ethylene oxide gas). For single use only.
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STORAGE
Store in a cool, dry place. Keep away from sunlight. DO NOT use the device after the "Use By" date specified on the label.
DISPOSAL INSTRUCTIONS
After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and
applicable local, state and federal laws and regulations.
CLINICAL USE INFORMATION
aggregation should be considered when the device is placed in iliac or femoral arteries.
C ™ P
OVERA LUS Vascular Covered Stent should be used only by physicians who are familiar with the complications, side
effects, and hazards commonly associated with dialysis access shunt revisions and endovascular procedures.
™ P
Vascular Covered Stent is MR Conditional for the placement of
LUS
MATERIALS REQUIRED FOR THE C
OVERA
system
INSTRUCTIONS FOR USE
Preparation
1. After removal from the packaging, verify that the safety lock is in the locked position.
NOTE:
After reading, tear off the paper hang tag with the safety notes from the handle of the 9F endovascular system.
2. Using standard endovascular access techniques and fluoroscopy, access the target vessel from a site that permits the
straightest possible path to the target lesion and advance an 0.035 inch (0.89 mm) guidewire across the target lesion.
3. For contralateral procedures, a long crossover introducer sheath or guiding catheter must be placed across the aortoiliac
bifurcation.
4. Pre-dilate the stenosis with a PTA balloon catheter of appropriate length and diameter for the lesion to be treated.
5. Select the appropriate covered stent diameter based on the sizing table (Table 1).
6. Examine the packaging and delivery system to determine whether there is any damage or whether the sterile barrier has
been compromised. Do not use the device if any of these conditions are observed.
7. Flush the delivery system through the Luer port at the proximal end of the handle with sterile saline until saline drops from
the tip of the system (Figure 4).
Figure 4
NOTE: Do not retract the red safety lock until the covered stent is positioned across the lesion and ready to be
deployed.
Delivery System Introduction
8. Under radiographic guidance, advance the delivery system over the guidewire past the target lesion and then pull back
slightly on the entire system to attain correct positioning of the radiopaque markers. Use the radiopaque covered stent ends
to center the covered stent across the lesion (Figure 5).
Figure 5
5
™ P
LUS VASCULAR COVERED STENT PROCEDURE