(2)
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.
Reference Precaution #4 and Warning #8.
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
).
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
(
Reference Figure 3
).
Figure 3
Perform the proximal arterial anastomosis using standard surgical techniques. In
order to retain the cuffed configuration, only the proximal end of the
D
YNAFLO
®
graft should be sized for length.
Thrombectomy
Techniques for declotting
D
YNAFLO
®
bypass grafts include but are not limited to
the use of balloon catheters.
Reference Warning #9
.
Longitudinal Incision:
Place stay sutures before introducing the embolectomy catheter. For
D
YNAFLO
®
Flex grafts, 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 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.
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 4
).
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 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
2
. 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.
Reference
Warnings #5, #6, and #7
.
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.
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.
ENGLISH
Specific Operative Procedures
