Bard Peripheral Vascular VENAFLO II ePTFE Mode D'emploi page 4

V
®
ENAFLO II ePTFE Vascular Grafts in Looped Anatomical Configurations:
Perform an incision to expose the artery and vein to be anastomosed and a
counter-incision at the site where the graft will curve. For C
this is where the flexed portion of the graft should be placed. Position the graft
overlying the forearm to optimize graft placement prior to tunneling. Introduce the
tunneler at the counter-incision site.
After creating the first tunnel, replace the bullet tip (if necessary), attach the
arterial end of the graft to the tunneler, and pull the graft through the tunnel
leaving the cuffed end exposed near the vein to be anastomosed.
For the second tunnel, repeat the tunneling procedure, initiating the tunnel at
the anastomotic site and advancing it down to the counter incision. (See Figure
4.) Once again, ensure that the venous (cuffed) graft end does not pass into the
tunnel.
Only the arterial end of the V
ENAFLO
length.
Suturing
Size the graft appropriately to minimize excessive tension at the suture line.
Use a tapered, non-cutting needle with a non-absorbable monofilament suture
approximately the same size as the needle. Take 2 mm 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. See Precaution #3.
Suggested Suturing Technique
After sizing the cuff to the vein diameter, perform a venotomy five to eight
millimeters shorter than the length of the cuff.
Using double-armed suture, tack the heel of the cuff, aligning the toe in the
direction of venous blood flow.
Suture continuously from the heel to just beyond the midpoint of the cuff on one
side of the venotomy. Using the other arm of the heel suture, continue suturing to
just beyond the midpoint of the graft on the other side of the venotomy.
Extend the venotomy to the exact cuff length. (See Figure 5.)
Complete the "cuffed" anastomosis by suturing with one of the suture arms,
around the toe, to the other side of the cuff. Always tie off on the side of the cuff
(See Figure 6).
Perform the arterial anastomosis using standard surgical techniques. In order
to retain a cuffed configuration, only the arterial end of the V
vascular graft should be sized for length.
Thrombectomy
Techniques for declotting V
ENAFLO
limited to the use of balloon catheters. See Warning #9.
Longitudinal Incision:
Place stay sutures before introducing the embolectomy catheter. (If the graft is
a C F ™ product, cut through the spiral beading and base tube. After
ENTER LEX
closure, the spiral beading will realign itself.) 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 wound 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 the procedure, the artery
proximal to the graft should be used for injection, if possible.
Blood Access
Best results are achieved by:
1 Leaving the graft in place for approximately two weeks prior to use. Immediate
use may increase the risk of hematoma formation.
F
ENTER LEX
Figure 4
®
II ePTFE vascular graft should be sized for
Figure 5
Figure 6
®
ENAFLO
®
II ePTFE vascular grafts include but are not
2. Inserting blood access needle at a 20° to 45° angle, with the bevel up until
the graft is penetrated, and then advancing the needle parallel to the graft.
™ grafts,
Routine flipping of needles is not recommended.
3 ROTATING THE CANNULATION SITES. Repeated cannulation in the same
area may lead to formation of hematoma or pseudoaneurysm.
4. Cannulating greater than a dialysis needle's length of the proximal
anastomosis. See Precaution #4.
5. Strictly adhering to aseptic technique to minimize infection.
6. Applying moderate digital pressure to the cannulation site after needle
withdrawal. This compression aids in hemostasis.
Note: There should always be a pulse or thrill near equal intensity proximal
and distal to the area of compression. Ensure that hemostasis is maintained
with the least amount of pressure required.
References
1. "Perigraft Seromas, Complicating Arterial Grafts", Robert M. Blumenberg,
M.D., et al, Surgery, Vol. 97, No. 2, February 1985.
2. Guide to the Safe Handling of Fluoropolymer Resins, 4th Edition, The
Fluoropolymers Division of the Society of the Plastics Industry, Inc.
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 Peripheral Vascular to see if additional product information is available.
II ePTFE
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