FDA Warns of Carotid Endarterectomy Patients of Serious Bleeding Risks Due to Baxters Vascu Guard Peripheral Vascular Patch
In breaking news, the Food and Drug Administration is reporting that the agency has received multiple adverse event reports from Baxter International Inc. regarding its Vascu-Guard Peripheral Vascular Patch, also known as the Vascu-Guard patch. The medical device is used during carotid endarterectomy (CEA), a procedure done to correct stenosis or narrowing of the carotid artery.
Baxter’s 2016 reports include serious incidents of intraoperative or postoperative bleeding and hematomas, which required additional medical interventions. These life-threatening Vascu-Guard complications potentially have lead to three patient deaths, which took place shortly after CEA surgery.
According to alert, 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. After CEA surgery, in particular, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.
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 the FDA is investigating, the agency is recommending “heightened post-operative vigilance” for any signs of early bleeding which can include swelling in the neck and/or difficulty breathing.
If you or a family member has experienced a serious injury or has died due to a bleeding issue or hematomas after having the Vascu-Guard patch during carotid endarterectomy procedure, Meyers & Flowers can help.
Meyers & Flowers has decades of experience fight for the rights of victims injured or killed due to defective and dangerous medical devices. We understand how to hold medical device manufacturers such as Baxter International accountable for their negligence and actions. Contact us at firstname.lastname@example.org, (630) 232-6333 or find out how we can help here.