FDA Warns of Adverse Events With Vascu-Guard in CEA

The US Food and Drug Administration (FDA) has received multiple adverse event reports associated with the use of the Vascu-Guard Peripheral Vascular Patch (Baxter International Inc) during carotid endarterectomy (CEA).

Events reported in recent months include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention. Three patient deaths were potentially related to such events, which occurred shortly after CEA surgery.

The patch is intended for use in peripheral vascular reconstruction, including for carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

Baxter alerted the FDA to the adverse events. The FDA issued a statement through its MedWatch Safety Information and Adverse Event Reporting Program.

"The FDA is 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," the agency writes in the safety warning, issued today. "After CEA 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 recommends that healthcare providers discuss with patients all available treatment options, including the risks and benefits of each, before deciding on the best treatment approach.

And until it completes its investigation of these adverse events, the agency also recommends that healthcare providers use heightened postoperative vigilance to look for signs of early bleeding, such as neck swelling or difficulty breathing, and to follow all manufacturer instructions for patch preparation.

Healthcare professionals and patients are encouraged to report adverse events or side effects to the FDA's MedWatch Safety Information and Adverse Event Reporting Program by completing and submitting the report online (www.fda.gov/MedWatch/report), or calling 800-332-1088 to request a form that can be faxed to 800-FDA-0178.

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Cite this: FDA Warns of Adverse Events With Vascu-Guard in CEA - Medscape - Sep 01, 2016.

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