FDA issues advisory on peripheral vascular patch used in carotid endarterectomy

The FDA sent a letter to health care providers after receiving reports of adverse events associated with use of a peripheral vascular patch during carotid endarterectomy procedures.

In the letter, the agency warned that patients treated with the product (Vascu-Guard Peripheral Vascular Patch, Baxter International) may be at risk for adverse events, including severe bleeding, hematomas, and death.

Adverse event reports included intraoperative bleeding, postoperative bleeding, hematomas (some needing additional intervention) and three patient deaths, the agency wrote, noting that most adverse events occurred soon after carotid endarterectomy.

“The FDA is concerned that the Vascu-Guard patch may not be performing as intended and that patients treated with the product may be at risk for serious adverse health consequences, such as severe bleeding, hematomas and death,” the FDA wrote. “After [carotid endarterectomy] surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.”

The FDA recommended the following to health care providers:

Discuss all available options with patients, including both risks and benefits of each option, before deciding the best approach for carotid endarterectomy.

Consider employing heightened postoperative vigilance for signs of early bleeding.

Follow all manufacturer instructions until the FDA completes its investigation.

Report any adverse events related to the patch to the FDA.

According to the letter, Baxter in June conducted a voluntary recall of the lot numbers linked with adverse event reports and has been working with the FDA to address the safety and effectiveness concerns, but the agency and the company are in the process of determining whether any additional lots need to be recalled.