The Vascu-Guard patch has been linked to reports of severe internal bleeding, blood clots, hematoma, embolisms, stroke, and death. The FDA is especially concerned when it is used to repair blood vessels in the neck.
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Baxter International Inc. manufactures the Vascu-Guard Peripheral Vascular Patch. It is a piece of cow tissue used for reconstructive surgery on major blood vessels in many parts of the body.
FDA Warning After Injuries & Deaths Reported
In September 2016, the FDA issued a Safety Alert for the Vascu-Guard after reports of severe bleeding, hematomas, and three patient deaths.
What is the problem?
The Vascu-Guard patch is associated with severe, life-threatening health risks — especially when it is used during Carotid Endarterectomy (CEA), which is a surgical procedure to open and clear blood vessels in the neck. According to the FDA:
“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.”
Doctors and patients should be vigilant for symptoms of bleeding in the neck, such as swelling or difficulty breathing.
The FDA also recommends considering other types of patches, including those made from pieces of a saphenous vein or prosthetic patches made out of Dacron or polytetrafluoroethylene (PTFE).
Analysis of the Problem
The label on the Vascu-Guard patch includes warnings about dehiscence (wound separation) at the surgical site, which could cause serious bleeding, hematomas, and infection. The FDA is investigating why so many reports of bleeding have been linked to CEA surgeries.
Vascu-Guard Patch Recall
In June 2015, Baxter issued a recall for the Vascu-Guard patch after
customers reported having problems implanting it correctly. Baxter received several reports of patients who experienced post-operative thrombosis (blood clots), embolisms, and strokes. Click here to read more.
What is a Hematoma?
A hematoma is an abnormal collection of blood outside a blood vessel but inside the body. They occur when a damaged blood vessel causes internal bleeding. Symptoms may include:
- Visible mass or lump
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