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Surgical Patch Recall; Risk of Severe Bleeding and Hematomas


 On July 6, 2017, Baxter International Inc. updated its June 24, 2016, recall of the Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch). Following Baxter International’s voluntary recall issued on June 24, 2016, the FDA has worked with the manufacturer to evaluate the severe bleeding and hematoma events reported following carotid endarterectomy (CEA) surgery. At this time, the FDA has not identified a root cause of the aforementioned bleeding events.

 

The FDA received multiple adverse event reports associated with Baxter International’s Vascu-Guard during CEA. These reports include intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths potentially related to this issue that occurred shortly after CEA surgery.

 

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. Patients with obstructive (atherosclerotic) or aneurysmal peripheral vascular disease who require surgical reconstruction could be exposed to this device, as could patients undergoing surgery on the carotid, renal, iliac, femoral, profunda, and tibial arteries. While this product can be used in other areas of the body, the FDA is aware of adverse events following CEA surgery.

 

Other vascular patches include those made from pieces of a saphenous vein or prosthetic patches made out of Dacron or polytetrafluoroethylene (PTFE).

 

See the FDA Safety Alert

 

See the Update Regarding Investigation of Reported Adverse Events

 

 

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