The U.S. Food and Drug Administration (FDA) has sent out a safety alert for Baxter International’s Vascu-Guard Peripheral Vascular Patch (also known as the Vascu-Guard patch).
The Vascu-Guard patch is intended for use in peripheral vascular reconstruction, including carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
The FDA received multiple adverse events reports about the Baxter patch during carotid endarterectomy (CEA), including intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention. Three patient deaths potentially related to the issue also occurred shortly after CEA surgery.
There has been concerns from the FDA that the Vascu-Guard patch may not be performing as intended and those that use the patch may be at risk for serious adverse health consequences, such as severe bleeding, hematomas, and death. In particular, after CEA surgery, arterial bleeding in the neck could lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.
The FDA recommends that health care providers discuss with patients all available treatment options, employ heightened post-operative vigilance on the part of the patient and physician for signs of early bleeding (e.g., neck swelling, difficulty breathing), and to follow all manufacturer instructions for patch preparation.
Any side effects or adverse events related to the use of the Vascu-Guard patch should be reported to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: http://www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178