The U.S. Food & Drug Administration (FDA) has received adverse event reports of bleeding, hematomas and death associated with the Baxter Vascu-Guard Peripheral Vascular Patch (“Vascu-Guard patch”) when used during carotid endarterectomy (CEA).
Free Confidential Lawsuit Evaluation: If you or a loved one suffered complications after receiving a Baxter Vascu-Guard Patch, you should contact our law firm immediately. You may be entitled to compensation by filing a suit and our lawyers can help.
Baxter Peripheral Vascular Patch Linked to Bleeding, Hematomas: FDA Warning
September 1, 2016 - According to an FDA Safety Alert issued today, the Vascu-Guard Patch has been associated with the following adverse events:
- Intraoperative bleeding
- Postoperative bleeding
- At least 3 patient deaths
All of these events occurred this year when the vascular peripheral patch was used during CEA surgery. Some complications required additional clinical intervention, according to the FDA.
The agency is concerned that the Vascu-Guard patch may not be performing as designed and that patients may be at risk for adverse health consequences. After carotid endarterectomy surgery, arterial bleeding in the neck could cause airway obstruction, hypoxia, diminished brain perfusion, stroke, heart attack and/or death.
FDA recommends that healthcare providers:
- Consult patients about the potential risks and benefits of all treatment options before deciding which course of action to take.
- Carefully monitor post-operative patients for signs of bleeding (e.g., neck swelling, difficulty breathing).
- Follow all manufacturer instructions for Vascu-Guard patch preparation.
Do I Have a Vascu-Guard Patch Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in vascular patch lawsuits. We are handling individual litigation nationwide and currently accepting new injury and death cases in all 50 states.
Free Confidential Case Evaluation: Again, if you were injured by a peripheral vascular patch, you should contact our law firm immediately. You may be entitled to a settlement by filing a suit and we can help.