Bard Covera Gebrauchsanweisung Seite 5

MAGNETIC RESONANCE IMAGING (MRI) SAFETY INFORMATION
Non-clinical testing has demonstrated that the C
overa
the arm for all clinically relevant lengths. Based upon the preclinical testing, patients with the C
be scanned safely, immediately after placement of this implant, under the following conditions:
• Static magnetic field of 1.5 Tesla or 3 Tesla.
• Spatial gradient field of 3000 Gauss/cm or less.
• Maximum whole-body-averaged specific absorption rate (SAR) of 1 W/kg for 15 minutes of scanning.
• Normal mode operation of the MR system.
NOTE: Failure to follow these conditions may result in injury to the patient.
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 6 x 100 mm
C ™ Vascular Covered Stent was determined to produce a potential worst-case temperature rise of 2.9 °C at a whole body SAR
overa
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 6 x 100 mm
C ™ Vascular Covered Stent was determined to produce a potential worst-case temperature rise of 2.7 °C at a whole body
overa
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
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. Artifact tests were performed according to ASTM F2119-07. 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 ™ Vascular Covered Stent has not been evaluated in MRI systems with field strengths other than 1.5 or 3.0 Tesla. The
overa
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.
STORAGE
Keep away from sunlight. Keep dry.
PATIENT IMPLANT CARD AND PATIENT INFORMATION BROCHURE
A Patient Implant Card is provided within this IFU. The patient, implant and hospital information should be recorded on the card
as requested. Ensure a peel-away sticker from the product label is placed on the card before it is given to the patient. The sticker
contains important information about the implant. The patient should carry the implant card with them and present it to any
medical personnel involved in their care.
Please visit eIFU.bd.com for the Patient Information Brochure. The brochure should be made available to the patient. It contains
additional important information about this product.
CLINICAL USE INFORMATION
• Antibiotic therapy may be prescribed at the physician's discretion.
COVERED STENT SIZE SELECTION
Special care must be taken to ensure that an appropriately sized device is selected. In the case of a diameter difference between
the inflow and the outflow end, always use the inflow vessel or AV graft diameter as the reference vessel diameter.
™ Vascular Covered Stent is MR Conditional for placement in the vessels of
™ Vascular Covered Stent can
overa
Table 3: Covered Stent Diameter Selection
Covered Stent Diameter
6 mm
7 mm
8 mm
9 mm
10 mm
Covered Stent Length
Ensure the selected covered stent length covers the entire lesion and both ends of the implant extend at least 5 mm into the
non-diseased segment of the vessel.
For covered stent placements in the proximal cephalic arch select the length so that the ostial lesion is fully covered and that the
proximal covered stent end does not compromise the flow in the axillary / subclavian vein. Ensure that the covered stent end
extends at least 10 mm beyond the arch curvature into the straight distal cephalic vein segment.
NOTE: The C ™ Vascular Covered Stent foreshortening is ≤ 10%.
overa
MATERIALS REQUIRED FOR THE C
overa
• Normal, sterile saline
• Sterile Luer lock syringes
• Contrast medium
• 0.035 inch (0.89 mm) guidewire of appropriate length to allow safe delivery of the covered stent and removal of the delivery
system
• Introducer sheath with appropriate inner diameter
• Diagnostic catheters and accessories
• Balloon angioplasty catheter for pre and/or post dilation
• Inflation device
INSTRUCTIONS FOR USE
Preparation
1. 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 of appropriate length across the
target lesion.
2. Pre-dilate the stenosis with a PTA balloon catheter of appropriate length and diameter for the lesion to be treated.
3. Select the appropriate covered stent diameter based on the sizing table (Table 3).
4. Open the box and remove the pouch containing the device.
5. Carefully inspect the pouch to ensure that the sterile barrier has not been compromised. Peel open the pouch and remove the
tray containing the delivery system. Carefully extract the delivery system from the tray.
6. Examine the delivery system to ensure it has not been damaged during shipment and that its size, shape and condition are
suitable for the procedure for which it is to be used. If it is suspected that the sterility or performance of the delivery system
has been compromised, the device must not be used.
7. Verify that the safety lock slider is still in the locked position (Figure 4).
8. Visually inspect the distal end of the delivery system to ensure that the covered stent is contained within the sheath. Do not
use if the covered stent is partially deployed.
9. Wipe the usable length portion of the delivery system with gauze soaked with sterile saline.
10. 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 5).
5
Recommended Oversizing Reference Vessel Diameter
0.5 mm – 1.5 mm 4.5 mm – 5.5 mm
0.5 mm – 1.5 mm 5.5 mm – 6.5 mm
1 mm – 2 mm 6 mm – 7 mm
1 mm – 2 mm 7 mm – 8 mm
1 mm – 2 mm 8 mm – 9 mm
™ VASCULAR COVERED STENT PROCEDURE