The FDA is warning about the risk of severe internal bleeding when the Vascu-Guard patch is used to repair blood vessels in the neck. It has also been linked to reports of blood clots, hematoma, embolisms, stroke, and death.
What You Can Do & How We Can Help
The Schmidt Firm, PLLC is currently accepting Vascu-Guard induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
Overview
Vascu-Guard Peripheral Vascular Patch is a medical device manufactured by Baxter International. It is made of cow tissue and is used to reconstruct major blood vessels in many areas of the body.
FDA Safety Alert — Injuries & Deaths Reported
September 1, 2016 — The FDA issued a Safety Alert for Vascu-Guard after receiving reports of severe internal bleeding, hematomas, and three patient deaths.
What is the problem?
The FDA is investigating a cluster of bleeding injuries in patients undergoing Carotid Endarterectomy (CEA) — surgery to clear an artery in the neck to prevent strokes. 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.”
Recommendation For Patients & Doctors
Patients and doctors should be vigilant for swelling and trouble breathing, which may be signs of bleeding in the neck. The FDA also recommends considering the risks and benefits of other vascular patches, including synthetic patches and those made from pieces of a saphenous vein.
FDA Investigates the Problem
Baxter has provided warnings about dehiscence (wound separation) in patients who receive the Vascu-Guard. This complication could cause severe bleeding, hematomas, and infection. The FDA is currently investigating a cluster of bleeding events following CEA surgeries.
Baxter Recalls Vascu-Guard Patch
June 1, 2015 — Baxter International recalled the Vascu-Guard patch after customers reported having problems orienting the patch during surgeries. Several patients experienced post-operative thrombosis (blood clots), embolisms, and strokes. Click here to read more.
What is a Hematoma?
A hematoma is a semi-solid mass of blood that accumulates under the skin after a blood vessel is broken. The symptoms may include:
- Pain
- Swelling
- Redness
- Bruising
- Weakness
- Visible lump
Do I have a Vascu-Guard Lawsuit?
The Schmidt Firm, PLLC is currently accepting Vascu-Guard induced injury cases in all 50 states. If you or somebody you know has been injured, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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