Bard Peripheral Vascular Distaflo Bypass Grafts Mode D'emploi page 4

Tunneling Recommendations
Note: Prior to utilizing a sheath tunneler, verify that the D
O.D. dimensions fit the sheath I.D. dimensions.
Use of a sheath tunneler is recommended for placing the D
graft. Use of a sheath tunneler will minimize graft handling, protect the
external reinforcement (Flex beading) and help maintain graft integrity.
Always follow the instructions for use for the specific tunneler utilized to place
ISTAFLO ®
the D bypass graft.
Create a tunnel that closely approximates the outer diameter of the graft.
A tunnel that is too loose may result in delayed healing and may also lead to
perigraft seroma formation. See Warnings #8 and #15.
ISTAFLO ®
Anastomotic Preparation of D
Use sterile technique to remove the Flex beading. Hold the graft firmly with
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 appropriate length at the non-cuffed
end.
Suturing
Size the graft appropriately to minimize excessive tension at the suture line.
Use a tapered, non-cutting needle with a nonabsorbable 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. Reference Warning #7 and
Precaution #5.
Suggested Suturing Technique
Perform an arteriotomy 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 distal blood flow.
Suture continuously from the heel to just beyond the midpoint of the cuff on
one side of the arteriotomy. Using the other arm of the heel suture, continue
suturing to just beyond the midpoint of the graft on the other side of the
arteriotomy.
Extend the arteriotomy to the exact cuff length (reference Figure 2).
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 3).
Perform the proximal arterial anastomosis using standard surgical techniques.
In order to retain the cuffed configuration, only the proximal end of the
ISTAFLO ®
D graft should be sized for length.
Thrombectomy
ISTAFLO ®
Techniques for declotting D
to the use of balloon catheters. See Warning #9.
Longitudinal Incision:
Place stay sutures before introducing the embolectomy catheter. Cut through
the spiral beading and base graft. The spiral beading will realign itself after
closure. Place a longitudinal incision in the graft that is long enough to
accomodate 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.
ISTAFLO ®
ISTAFLO ®
Grafts with Flex Beading
Figure 2
Figure 3
bypass grafts include but are not limited
graft
Extra-Anatomic Bypass Procedures (e.g., Axillofemoral, Femoral
bypass
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 Precaution #4 and #5 and
Warning #6 and #7.)
• 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 4.)
• Cutting the graft slightly longer than necessary has been reported by
some surgeons to further reduce 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 (0°) 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
2
axillary artery. Do not place the anastomosis on the third portion of the
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. See Warning #5, #6 and #7, and Precaution #5.
References
1. Guide to Safe Handling of Fluoropolymer Resins, Fourth Edition, The
Fluoropolymer Division of the Society of 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.
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.
(2)
Specific Operative Procedures
Figure 4