A PATIENT, 68, had axillofemoral bypass graft surgery for severe aortoiliac occlusive disease. On the 13th postoperative day, the bypass graft disrupted near the anastomotic suture line. (Although the adverse event report didn't include this patient's signs and symptoms, most patients develop axillary pain, an expanding hematoma, and pseudoaneurysm following surgical arm abduction and lateral flexion of the body.) The patient suffered a cardiac arrest. Although he was successfully resuscitated, he required massive blood transfusion and a below-the-knee amputation.

What went wrong?

Axillofemoral bypass is an extra-anatomical grafting procedure performed for patients with severe aortoiliac occlusive disease to improve arterial blood flow to the lower extremities. In the case described, the prosthetic graft was disrupted near the femoral artery anastomosis. The patient had reportedly been very actively turning in bed after the procedure, and placing stress on the graft caused anastomotic disruption.

What precautions can you take?

Though exertional graft disruption is rare, the Center for Devices and Radiological Health (CDRH) has received reports of this adverse event. These reports have described massive blood loss, loss of limb function, and sometimes death.

By following these precautions (in addition to using certain operative techniques), clinicians can reduce the risk of exertional graft disruption:

* Check the instructions for use in the prosthetic graft labeling to ensure that the graft is suitable for extra-anatomical bypass use. Also check for any warnings or cautions about this usage. Some thin-walled vascular grafts aren't recommended for axillofemoral bypass surgery due to the potential for graft disruption during extreme body movement.

* Ensure that the prosthetic graft is long enough so that it won't be stressed by patient activity, especially arm and leg movement.

* Teach the patient not to move his arms, shoulders, or legs suddenly, abruptly, or strenuously for 6 to 8 weeks after surgery to allow the graft anastomoses to heal adequately.

* Tell the patient to avoid certain routine activities, such as raising his arms higher than his shoulders, reaching out in front of himself, and performing extended reaching, throwing, pulling, striding, and twisting. He should avoid these activities for as long as his healthcare provider directs.

Report adverse events associated with medical devices to the FDA and the CDRH.