Contraindications, Warnings, Precautions

Notice

Please read all package inserts and instructions for use, contraindications, warnings, precautions, adverse reactions and administration before use.

Contraindications

The Artegraft should not be used in venous or low pressure systems. Once the package seal is broken, the graft should be used immediately; any left-over material should be discarded. The graft should not be used after the expiration date imprinted on the label.

Warnings

After the Artegraft has been removed from the container in the manner prescribed to preserve its sterility, it should be gently and thoroughly washed and rinsed to minimize carry-over of the preserving fluid. For aseptic removal and wash procedures, please see DOSAGE AND ADMINISTRATION section of the Instructions For Use. Silk is not recommended for anastomosis. This suture occasionally was found to give rise to thick suture-line pannus in the dog. The prosthesis is not to be used unless the capacity of the run-off vessel is adequate, as shown by preoperative arteriography. Artegraft selection must be of comparable cross-sectional diameter to the host artery, particularly at the distal end, in order to avoid early thrombosis. Thrombosis of the graft has been reported from inadvertent external compression. Patients and those administering dialysis should be cautioned against compression of the graft for prolonged periods.

Precautions

In the event of early occlusion, re-exploration of the graft and removal of the thrombus with a Fogarty catheter or other means often results in effective restoration of long-term patency. This procedure is somewhat easier to perform in the case of the Artegraft than with other prostheses. Patients subjected to heparin anticoagulant rinse and flush should be confirmed to be heparin-induced thrombocytopenia (HIT) free, and of heparin associated allergic reactions. Some surgeons recommend systemic heparinization of the patient after completion of the preparatory dissection, with or without subsequent neutralization with protamine sulfate. Others rely on the periodic injection of diluted heparin into the arterial tree during the period of vascular clamping and anastomosis. Postoperative heparinization is usually not employed. During implantation, meticulous technique is essential to avoid twisting and to achieve accurate approximation at the suture lines. Clinical evidence suggest that subfascial, rather than subcutaneous, implantation in the lower extremity is the more satisfactory procedure. For precautions regarding true aneurysms, please see ADVERSE REACTIONS section of the Instructions For Use.