Indications for Use
DISTAFLO® bypass grafts are intended for bypass or reconstruction of peripheral arterial blood vessels.
Contraindications
None known.
Warnings
1. All DISTAFLO® bypass grafts are supplied sterile and non-pyrogenic unless the package is opened or damaged. DISTAFLO® bypass grafts are sterilized by ethylene oxide.
2. Do not use after expiration date printed on the label.
3. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices – particularly those with long and small lumina, joints, and/or crevices between components – are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
4. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.
5. Anastomotic or graft disruption has been associated with Axillofemoral, Femoral Femoral, or Axillobifemoral bypass procedures if implanted improperly. Refer to Specific Operative Procedures (Extra-Anatomic Bypass Procedures) for further instructions.
6. For Extra Anatomic procedures (e.g. Axillofemoral, Femoral Femoral, or Axillobifemoral bypass), the patient should be cautioned that sudden, extreme or strenuous movements 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.
7. DISTAFLO® bypass grafts do not stretch (are non-elastic) in the longitudinal direction. The correct graft length for each procedure must be determined by considering the patient's body weight, posture, and the range of motions across the anatomical area of graft implantation. Failure to cut the graft to an appropriate length may result in anastomotic or graft disruption, leading to excessive bleeding, and loss of limb or limb function, and/or death.
8. Aggressive and/or excessive graft manipulation when tunneling, or placement within a too tight or too small tunnel, may lead to separation of the spiral beading and/or graft breakage. The distal anastomosis should be made after tunneling or suture disruption can occur. DO NOT pass the cuff portion (distal end) of the DISTAFLO® bypass graft through a tunneler sheath or the tissue tunnel, as this could lead to separation of the spiral beading and/or graft breakage.
9. When embolectomy or balloon angioplasty catheters are used 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 inappropriately sized balloon may dilate or damage the graft.
10. Avoid repeated or excessive clamping at the same location on the graft. If clamping is necessary, use only atraumatic or appropriate vascular smooth jawed clamps to avoid damage to the graft wall. Do not clamp the cuffed portion of the graft.
11. Exposure to solutions (e.g., alcohol, oil, aqueous solutions, etc.) may result in loss of the graft's hydrophobic properties. Loss of the hydrophobic barrier may result in graft wall leakage. Preclotting of this graft is unnecessary.
12. Avoid excessive graft manipulation after exposure to blood or body fluids. Do not forcibly inject any solution through the lumen of the graft, or fill the graft with fluid prior to pulling it through the tunnel as loss of the graft's hydrophobic properties may occur. Loss of the hydrophobic barrier may result in graft wall leakage.
13. Do NOT expose DISTAFLO® bypass grafts to temperatures greater than 500°F (260°C). PTFE decomposes at elevated temperatures, producing highly toxic decomposition products.
14. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.
15. During tunneling, 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.
