Baxter International, Inc. recently alerted the FDA of multiple adverse events associated with the company’s Vascu-Guard peripheral vascular patch, which is used during carotid endarterectomy.
The FDA said in a safety alert on Sept. 1 that three patient deaths were potentially related to issues with the Vascu-Guard shortly after undergoing carotid endarterectomy surgery. Baxter has also had reports this year of intraoperative bleeding and hematomas.
The Vascu-Guard patch is used in peripheral vascular reconstruction in patients with obstructive (atherosclerotic) or aneurysmal peripheral vascular disease. The FDA said that Baxter sent a safety alert to its customers and voluntarily recalled specific lots of the Vascu-Guard patch.
The FDA has classified Baxter’s voluntary recall as a Class II recall, which means the products might cause a temporary health problem or pose a slight threat of a serious nature or death. The FDA said it was still investigating the adverse event reports. Until the agency completes its investigation, healthcare professionals are advised to monitor signs of early bleeding and follow instructions for patch preparation.
“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 FDA said in the safety alert. “After [carotid endarterectomy] surgery in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.”