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Avoid protracted hyperabduction of the arm. Prolonged hyperabduction may lead to brachial plexus injury.
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To promote satisfactory healing, the patient should avoid extreme or abrupt movements of the arm,
shoulder, or legs during a post-operative period of 1.5 to 2 months. Specifically, the patient should not reach
out in front, raise arms above shoulder level, throw, pull, stride, or twist.
Vascular (Blood) Access
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Patient monitoring is essential when the graft is used for vascular access to prevent excessive damage from
complications such as infiltration, infection, thrombosis, embolism etc.
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To minimize subcutaneous bleeding during implantation, create a subcutaneous tunnel that approximates
the size of the diameter of the graft.
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Rotate cannulation sites to prevent complications such as a disruption of the graft material and formation of
a perigraft hematoma or pseudoaneurysm.
Post Surgery Invasive Procedures
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LifeSpan ePTFE grafts are not radially elastic. Therefore, when performing an embolectomy using balloon
angioplasty catheters within the lumen of the graft, the inflated balloon size must match the inner diameter
of the graft. Over-inflation of the balloon or use of an inappropriate sized catheter may damage the graft
and/or the balloon.
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If thrombectomy is necessary during the early post-operative period, a longitudinal incision with stay
sutures is recommended.
Possible Complications with Vascular Protheses
Failure to follow proper techniques discussed under Warnings, Surgical Precautions, and Special Considerations may result
in:
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Mechanical disruption or tearing of the graft, suture line, or host vessel.
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Extreme blood loss
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Loss of limb function, limb, or death.
In addition, life threatening complications which may occur in conjunction with the use of any vascular prosthesis include,
but are not limited to: Excessive suture hole bleeding; thrombosis; thromboembolic complications; infection; ultrafiltration
or perigraft seroma; swelling of limbs; pseudoaneurysms; perigraft hematomas; skin erosion; steal syndrome; preoperative
hemorrhage; aortoenteric fistula.
Complications due to individual patient reaction to an implanted device, or to physical or chemical changes in the
components, may necessitate reoperation and replacement (sometimes within hours or days) of the prosthetic device.
Careful and continuous medical follow-up is advised so that prosthesis-related complications can be diagnosed and properly
managed to minimize danger to the patient.
Sterility
The LifeSpan ePTFE vascular graft is supplied sterile and nonpyrogenic if the package has not been previously opened and
is undamaged. Provided that the integrity of the package is not compromised, the package will serve as an effective barrier
for a minimum of 5 years from the sterilization date. The graft is supplied in double plastic trays to facilitate handling and
transfer to the sterile field during surgery. After opening the outer tray, the inner tray may be placed directly into the sterile
field.
To open, hold the base of the outer tray, peel back the lid so that the inner tray can be removed by grasping the sealed
lip. Beginning at one corner, peel back the inner tray lid and gently remove the graft. Use clean gloves or atraumatic
instruments when handling the graft.
Resterilization
When resterilization is performed, each institution should establish sterilization procedures that include biological
indicators to establish the efficacy of their procedure. Sterilizers should be validated on a regular basis. The LifeSpan ePTFE
vascular grafts can be resterilized ten times by steam as long as contamination with blood or any foreign material has not
occurred. To resterilize, gently remove the graft from the plastic tray with clean atraumatic instruments or gloved hands and
place in a hospital sterilization pouch. Do not use tray to perform autoclave resterilization procedures. Do not sterilize with
any type of radiation sterilization equipment.
Normal autoclave cycle (gravity displacement steam sterilizer):
250°F (121°C) for 30 - 40 minutes or
270°F (132°C) for 15 - 20 minutes.
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