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exert too much pressure with solution as possible seroma formation may result.
Special Considerations
Extraanatomic Bypasses: Axillofemoral and Femorofemoral Grafts
The following techniques must be used when performing these procedures:
•
Prepare and drape the patient to allow full extension of the arm, shoulder girdle, or legs when determining appropriate graft length (refer to Warning #6 and Surgical
Precautions subsection: Cutting). Prep the arm circumferentially to facilitate its movement during the procedure to check tension of the graft and prevent kinking.
•
Separate the fi bers of the pectoralis major and divide the pectoralis minor tendon to avoid angulation of the graft. The fi rst and second portions of the axillary artery must
be dissected and controlled and appropriate area for anastomosis selected.
•
When dissections are complete, the subcutaneous tunnel should be made by curving to the mid-axillary line to avoid angulation over the costal margin in the sitting
position.
•
Position the axillary anastomosis medially in the fi rst third of the axillary artery in the subfascial plane under the pectoralis major muscle and the external oblique fascia to
aid in preventing anastomotic disruption. The third portion of the artery should never be used for bypass because shoulder motion aff ects this segment.
•
Anastomose the graft as perpendicular to the axillary artery as possible to minimize stress. The anastomotic angle should be as small as possible and should not exceed 25°
relative to the cut edge of the graft.
•
Avoid protracted hyperabduction of the arm. Prolonged hyperabduction may lead to brachial plexus injury.
•
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.
Specifi cally, the patient should not reach out in front, raise arms above shoulder level, throw, pull, stride, or twist.
Vascular (Blood) Access
•
Patient monitoring is essential when the graft is used for vascular access to prevent excessive damage from complications such as infi ltration, infection, thrombosis,
embolism etc.
•
To minimize subcutaneous bleeding during implantation, create a subcutaneous tunnel that approximates the size of the diameter of the graft.
•
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
•
LifeSpan ePTFE grafts are not radially elastic. Therefore, when performing an embolectomy using balloon angioplasty catheters within the lumen of the graft, the infl ated
balloon size must match the inner diameter of the graft. Over-infl ation of the balloon or use of an inappropriate sized catheter may damage the graft and/or the balloon.
•
If thrombectomy is necessary during the early post-operative period, a longitudinal incision with stay sutures is recommended.
Possible Complications with Vascular Prothesis
Failure to follow proper techniques discussed under Warnings, Surgical Precautions, and Special Considerations may result in:
•
Mechanical disruption or tearing of the graft, suture line, or host vessel.
•
Extreme blood loss
•
Loss of limb function, limb, or death.
•
Stenosis
•
Perioperative cardiac, respiratory, and gastrointestinal complications
•
Renal insuffi ciency
•
Stroke
•
Lymphorrhea
•
Vascular access dysfunction
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; ultrafi ltration or perigraft seroma; swelling of limbs; pseudoaneurysms; perigraft hematomas; skin erosion; steal syndrome;
preoperative hemorrhage; aortoenteric fi stula.
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 eff ective barrier for a minimum of 7 years from the sterilization date. The graft is supplied in double plastic trays to facilitate handling
and transfer to the sterile fi eld during surgery. After opening the outer tray, the inner tray may be placed directly into the sterile fi eld.
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/Re-use
This device is single-use only. Do not reuse, reprocess, or re-sterilize. The cleanliness and sterility of the re-processed device cannot be assured. Reuse the device may lead to cross
contamination, infection, or patient death. The performance characteristics of the device may be compromised due to reprocessing or re-sterilization since the device was only designed
and tested for single use. The shelf life of the device is based on single use only. If for any reason this device must be returned to LeMaitre Vascular, place it in its original packaging and
return it to the address listed on the box.
Storage
To minimize contamination and to provide maximum protection, the prosthesis in the outer wrap should be stored in the outer cardboard box in a dry, contamination-free area until
needed. Stock rotation at regular intervals is recommended to ensure usage of the graft prior to the "use by" date stamped on the label.
Safe Handling and Disposal
If serious medical incidents should arise during use of this medical device, users should notify both LeMaitre Vascular and the Competent Authority of the country where the user is
located.
This product contains no sharps, heavy metals or radioisotopes, and is not infectious or pathogenic. No special requirements for disposal are evident. Please consult local regulations to
verify proper disposal.
Packaging and Shipping of Explanted LifeSpan:
Return of the shipment to LeMaitre Vascular depends on 3 crucial questions:
1.
Is the explant obtained from a patient with a known or presumed pathogenic condition at the time of the explant?
2.
Is the explant obtained from a patient that has a known treatment history that involves therapeutic radionuclides within the last 6 months?
3.
Has the clinician obtained consent from the patient for the sample to be returned to the manufacturer for research purposes?
In the event that the response to question 1 or 2 is affi rmative, LeMaitre Vascular does not provide adequate guidance for shipment. THESE EXPLANTS SHOULD NOT BE RETURNED TO
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