FDAnews Device Daily Bulletin

FDA Cautions Healthcare Providers of Risks of Peripheral Vascular Patch

Sept. 6, 2016

The FDA is concerned about the adverse event reports associated with Baxter International’s Vascu-Guard Peripheral Vascular Patch.

The agency has been receiving reports of intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, after patches were used in carotid endarterectomy surgery. The reported events include three patient deaths potentially related to this issue that occurred shortly after CEA surgery.

The FDA has recommended that healthcare providers talk with their patients about alternative treatment options and the benefits of each before selecting an option, and if the patch is used, to employ heightened postoperative vigilance by both the patient and the physician for signs of early bleeding. — Derek Major

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