Cowper Law is investigating whether there is a relationship between the Vascu-Guard patch that is placed during a carotid endarterectomy (CEA) and intraoperative and postoperative bleeding as well as patient death.
On June 1, the pharmaceutical company Baxter and the FDA issued a voluntary recall of multiple lots of the Baxter Vascu-Guard Peripheral Vascular Patch. This was categorized as a Class 1 recall which means that the device is believed to have side effects which may be potentially fatal.
In the recall notice, Baxter states, “[we have] received a limited number of adverse event reports, including postoperative thrombosis and stroke, in which the recalled product codes have been used. Baxter is continuing to investigate these reports. There is an inherent risk of thrombosis associated with vascular procedures in this patient population with underlying vascular diseases. At this point, no causal association has been established.”
On September 1, 2016, the FDA issued a letter to Health Care Providers and wrote: “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 warning letter can be found here: http://www.fda.gov/safety/medwatch/safetyinformation/safetyalertsforhumanmedicalproducts/ucm518852.htm
If you have experienced complications as a result of a Vascu-Guard Peripheral Vascular Patch, please call Cowper Law at 877.LAW.3707 to speak with an attorney about your rights. We are attorneys with experience in medical device and pharmaceutical litigation. Let us help fight for you.