Updated to clarify the recent notice did not relate to a recall initiated in June 2015.
The FDA today released a notice warning of issues with Baxter‘s (NYSE:BAX) Vascu-Guard peripheral vascular patch after receiving multiple adverse event reports including 3 patient deaths potentially related to the issue.
The Vascu-Guard patch is designed for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund and tibial blood vessels and arteriovenous access revisions, the FDA said.
The federal watchdog said it has received reports of issues with intraoperative or postoperative bleeding and hematomas, some of which required clinical interventions and 3 patient deaths which occurred shortly after carotid endarterectomy procedures.
The agency said it 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,” according to its safety communication.
The FDA said that after CEA surgery in particular, arterial bleeding in the neck could cause airway obstruction, hypoxia, diminished brain perfusion, stroke or cardiac arrest.
The federal watchdog recommended that health care providers who work with the patch discuss treatment options with patients and “employ heightened post-operative vigilance” to watch for signs of early bleeding.
The federal watchdog said it has been working with the company since it initiated a voluntary recall of select lots of the patches in June, which the agency classified as a Class II recall in August.
Baxter is cooperating with the FDA to determine whether the initial recall covers all lots that could be associated with similar adverse events, the agency said.
Last June, Baxter initiated a select recall of its Vascu-Guard peripheral vascular patches packaged under 4 specific product codes.
The FDA labeled the recall as a Class I, the most serious type of recall issued by the federal watch dog, which indicates that “there is a reasonable probability that use of these products will cause serious adverse health consequences or death.”
Deerfield Park, Ill.-based Baxter said it received complaints over the patches from customers who were unable to distinguish the smooth and rough surfaces of the patch as described in the instructions. The deviation is due to a new packaging configuration, the company said.
Incorrect orientation upon implantation, with the rough side towards the bloodstream, could increase the risk of vessel thrombosis and/or embolisms, the company said in a release published by the FDA.
The FDA added that the defect “may expose patients to significant health risks, including the movement of blood clots into the blood stream (embolism), reduced blood flow, stroke, organ failure, or death.”
