Bard ePTFE IMPRA Instructions D'utilisation page 4

Anastomotic Preparation of Grafts with Flex Beading
Use sterile technique to remove the Flex Beading. Hold the graft firmly in one
gloved hand. With the other gloved hand, gently grasp and lift the end of the
beading with gloved fingers. Slowly unwind the beading by peeling at a 90° angle
to the graft. (Reference Figure 1 and PRECAUTION #3). Remove and trim off
enough beading to cut the graft to length.
Suturing
Size the graft appropriately to minimize excessive tension at the suture line.
Use a tapered, noncutting needle with a nonabsorbable monofilament suture
approximately the same size as the needle. Take 2mm suture bites in the graft
following the curve of the needle and gently pull the suture at a 90° angle. Proper
sizing of the graft length prior to implant will minimize suture hole elongation
caused by excessive tension. Reference PRECAUTION #3 and WARNING #7.
Thrombectomy
Techniques for declotting I grafts include but are not limited to the use of
®
MPRA
balloon catheters. Reference WARNING #9.
Longitudinal Incision: Place stay sutures before introducing the embolectomy
catheter. For I F LEX ™ products, cut through the spiral beading and base
MPRA
graft. The spiral beading will realign itself after closure. Place a longitudinal
incision in the graft that is long enough to accommodate the extraction of a fully
dilated thrombectomy catheter balloon. A patch may be considered as an aid to
graft closure.
Transverse Incision: No stay sutures are necessary. A horizontal mattress
suture is recommended for graft closure.
During the early postoperative period, the natural progression of healing renders
the graft translucent in appearance. In this state, a longitudinal incision with
stay sutures is recommended. If a transverse incision is performed, a horizontal
mattress suture technique and PTFE pledgets may aid in closure.
Angiography
Should angiography be performed at the time of procedure, the artery proximal to
the graft should be used for injection if possible.
Specific Operative Procedures
Extra-Anatomic Bypass Procedures (e.g., Axillofemoral, Femoral Femoral,
and Axillobifemoral)
For Extra-Anatomic bypass procedures, careful attention must be given to the
following techniques. Failure to follow these technical considerations may result
in suture hole elongation, mechanical disruption, or tearing of the graft, suture
line or host vessel, thrombosis, extreme blood loss, loss of limb function, loss of
limb, or death. Reference WARNING #7 and PRECAUTION #4.
• To avoid extreme stress on the anastomosis and the graft, include the
patient's weight and range of limb motion when determining graft length,
tunnel length and location.
• To determine the correct graft length, drape the patient to allow full
movement of the arm, shoulder girdle or legs.
• Avoid protracted hyperabduction of the arm, during the surgical procedure.
Prolonged hyperabduction may lead to brachial plexus injury.
• Allow sufficient graft length to avoid stressing of axillary or femoral
anastomosis throughout the full range of movement of the arm, shoulder
girdle, or legs. The graft should be placed under both the pectoralis major
and pectoralis minor. (Reference Figure 2.)
• Cutting the graft slightly longer than necessary has been reported by some
surgeons to reduce further the risk of stressing the graft or the anastomosis.
• Correctly bevel the axillary anastomosis. Stress on the graft is minimized
when the graft is placed perpendicular to the axillary artery. Therefore, the
anastomotic angle should be as small as possible and should not exceed
25° relative to the cut edge of the graft.
• Place the graft anastomosis close to the rib cage on the first portion of the
axillary artery . Do not place the anastomosis on the third portion of the
2
axillary artery.
• Notify the patient that sudden, extreme or strenuous movements of the
arm, shoulder or leg should be totally avoided for a period of at least six to
eight weeks to allow for proper stabilization of the graft. Routine activities
such as raising the arms above the shoulders, reaching out in front,
extended reaching, throwing, pulling, striding, or twisting should be avoided.
Reference WARNING #5, #6, and #7.
Blood Access Procedures
Leave the graft in place for approximately two weeks prior to use. There is an
increased risk of hematoma formation if the graft is punctured prior to complete
healing.
1. Insert the blood access needle at a 20° to 45° angle, with the bevel up.
When the graft is penetrated, advance the needle parallel to the graft.
2. ROTATE (CHANGE) THE CANNULATION SITES.
Figure 2
3. Do not repeat cannulation in the same area. Repeat cannulation may lead
to formation of a hematoma or a pseudoaneurysm. Do NOT cannulate
within the dialysis needle's length of the proximal and distal anastomosis.
4. Strictly adhere to aseptic technique to minimize infection.
5. Apply moderate digital pressure to the cannulation site after needle
withdrawal. This compression assists in hemostasis.
Note: There should always be a pulse or thrill of near equal intensity
proximal and distal to the area of compression.
6. Instruct the patient as to proper postoperative care. Reference WARNING
#10 and #11.
References
1. Guide to the Safe Handling of Fluoropolymer Resins, 4th Edition, The
Fluoropolymers Division of the Society of The Plastics Industry, Inc.
2. Victor M. Bernhard, M.D. and Jonathan B. Towne, M.D., Editors,
Complications in Vascular Surgery, Second Edition, Grune and Stratton, Inc.
(Harcourt Brace Jovanovich; Publishers), Orlando, 1985, 56.
3. "Perigraft Seromas, Complicating Arterial Grafts", Robert M. Blumenberg,
M.D., et al, Surgery, Vol. 97, No. 2, February 1985.
Warranty
Bard Peripheral Vascular warrants to the first purchaser of this product that this
product will be free from defects in materials and workmanship for a period of
one year from the date of first purchase and liability under this limited product
warranty will be limited to repair or replacement of the defective product, in Bard
Peripheral Vascular's sole discretion or refunding your net price paid. Wear and
tear from normal use or defects resulting from misuse of this product are not
covered by this limited warranty.
TO THE EXTENT ALLOWABLE BY APPLICABLE LAW, THIS LIMITED
PRODUCT WARRANTY IS IN LIEU OF ALL OTHER WARRANTIES, WHETHER
EXPRESS OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED
WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR
PURPOSE. IN NO EVENT WILL BARD PERIPHERAL VASCULAR BE LIABLE
TO YOU FOR ANY INDIRECT, INCIDENTAL OR CONSEQUENTIAL DAMAGES
RESULTING FROM YOUR HANDLING OR USE OF THIS PRODUCT.
Some countries do not allow an exclusion of implied warranties, incidental or
consequential damages. You may be entitled to additional remedies under the
laws of your country.
An issue or revision date and a revision number for these instructions are
included for the user's information on the last page of this booklet. In the event 36
months have elapsed between this date and product use, the user should contact
Bard to see if additional product information is available.
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