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FDA received a cluster of bleeding event reports in 2016 associated with the Vascu-Guard Peripheral Vascular Patch from Baxter International. These events occurred during or shortly after carotid endarterectomy (CEA). Some of the events required unplanned interventions to manage the bleeding, and 3 deaths were associated with the patch. FDA states the patch may not be functioning correctly putting patients at risk for severe bleeding complications, including death. The risk seems to be particularly high after CEA surgery where bleeding in the neck area can cause airway obstruction leading to reduced brain perfusion, cardiac arrest, or stroke. However, patients may also be exposed to the patch for surgical reconstruction in obstructive or aneurysmal peripheral vascular disease or any surgery on the carotid, femoral, iliac, profunda, renal, or tibial arteries. Baxter previously recalled specific lots of the Vascu-Guard patch in June 2016 due to bleeding reports and is working with FDA in its investigation into these reports to see if other lots are associated with a similar bleeding risk. FDA published a letter to health care providers detailing the issue on September 1, 2016 (see link below).
The Vascu-Guard patch is marketed for peripheral vascular reconstruction of blood vessels (eg, carotid, femoral) and revisions of arteriovenous access sites. Vascu-Guard is prepared from glutaraldehyde cross-linked bovine pericardium. Other vascular patch options include saphenous vein grafts, and patches prepared from Dacron or polytetrafluoroethylene (PTFE). Providers should discuss all treatment options, including other reconstructive techniques with patients prior to CEA surgery. Consider increasing postoperative vigilance for early signs of bleeding after CEA surgery and closely follow all instructions for patch preparation and use until FDA completes its investigation into these bleeding events.
Additional Information:
- MedWatch Safety Alert – September 1, 2016
- Letter to Health Care Providers – September 1, 2016
- Vascu-Guard Patch Recall Notice – August 12, 2016 (original notification from Baxter June 24, 2016)