In a release by the U.S. Food and Drug Administration (FDA), the agency acknowledged that neither regulators nor manufacturers have determined the root cause of issues with Baxter’s Vascu-Guard peripheral vascular patch.
Mass Device reports that the Vascu-Guard patch is used in vascular reconstruction surgeries.
In September, the FDA said it had received reports of issues with intraoperative and/or postoperative bleeding and hematomas. Several of these instances required clinical interventions and three of the resulted in deaths.
All patient deaths occurred shortly after carotid endarterectomy procedures.
In their safety communication, the FDA stated that it was “concerned that the Vascu-Guard patch may not be performing as intended and that patients who are treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death.”
On July 6, the FDA acknowledged that the recall had been closed on June 23 but admitted that neither they nor Baxter discovered the root cause for the serious adverse events experienced by patients.
The FDA did recommend that healthcare providers continue to discuss the benefits and risks of Vascu-Guard as well as all other treatment options prior to CEA surgery.
The agency also requested that all adverse events related to Vascu-Guard patches be reported immediately.