The FDA issued a safety notice to healthcare providers warning of adverse events associated with Baxter International’s Vascu-Guard Peripheral Vascular Patch.
Adverse events include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related that occurred shortly after carotid endarterectomy (CEA) surgery. The agency said Baxter alerted the FDA to these adverse events.
After CEA surgery, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest, the notice said.
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.
As noted in the device labeling, possible complications from the patch include wound separation at the surgical site, which could cause serious bleeding, hematomas, and infection.
On Aug. 12, the FDA classified the recall as a Class II recall, which involves situations in which products might cause a temporary health problem, or pose only a slight threat of a serious nature or death.
Read the notice here: www.fdanews.com/09-01-16-Baxtersafetynotice.pdf. — Tamra Sami