FDA: Vascu-Guard Patch Associated With Bleeding, Death After Carotid Endarterectomy


The US Food and Drug Administration (FDA) is spreading the word that the Vascu-Guard Peripheral Vascular Patch, a device designed to prevent bleeding after carotid endarterectomy (CEA), has been tied to multiple cases of intraoperative or postoperative bleeding. Three patient deaths are potentially related to the complications, according to an FDA safety alert announced yesterday.

The device in question—the Vascu-Guard Peripheral Vascular Patch—is intended for use in peripheral vascular reconstruction involving carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.

According to an FDA letter to healthcare providers, this June manufacturer Baxter International “sent a safety alert to its customers, voluntarily recalling specific lots of the Vascu-Guard patch because of reports of intraoperative or postoperative bleeding and hematomas following CEA surgery, some of which required additional clinical intervention.”

Until the issue can be further investigated, the FDA recommends that providers speak with patients about “all available treatment options, including the risks and benefits of each, before deciding the best treatment approach,” as written in their safety alert. Additionally, the agency asks operators who decide to continue using the Vascu-Guard patch during CEA to “employ heightened postoperative vigilance on the part of the patient and physician for signs of early bleeding (eg, neck swelling, difficulty breathing)” and follow all manufacturer instructions for patch preparation.

The FDA is encouraging healthcare professionals and patients to report adverse events or side effects related to the use of these products to MedWatch.

 

Sources
  • US Food and Drug Administration. Vascu-Guard peripheral vascular patch by Baxter International: letter to health care providers - potential risk of severe bleeding and hematomas. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518852.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery. Published on: September 1, 2016. Accessed on: September 2, 2016.

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