The FDA today released an update on Baxter‘s (NYSE:BAX) voluntary recall of its Vascu-Guard peripheral vascular patch, saying that it is working with the company but that neither group has discovered a root cause for the issues, which led to a number of adverse events and 3 potential patient deaths.
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.
While the federal watchdog said it has yet to discover the cause of the issue, it did offer that so far, there have been no new events related to the issues during carotid endarterectomy surgeries since the recall was initiated last September.
The FDA said that the recall closed on June 23, and that it “continues to recommend that healthcare providers discuss with their patients all available treatment options for CEA surgery, including their benefits and risks, before deciding the best treatment approach,” according to a press release.
The agency also recommended any adverse events related to the Vascu-Guard patch be reported immediately.
In September, the FDA said it had 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 was “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.
