On September 1, 2016, the FDA announced that it has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA). CEA is a surgical procedure used to reduce the risk of stroke, by correcting stenosis (narrowing) in the common carotid artery or internal carotid artery by removing material from the inside of the carotid artery. These reports from 2016 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 device manufacturer, Baxter International, Inc., alerted the FDA to these adverse events.
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).
In June 2016, Baxter International, Inc. sent a safety alert to its customers, voluntarily recalling specific lots of the Vascu-Guard patch because of reports of intraoperative or postoperative bleeding and hematomas following CEA surgery, some of which required additional clinical intervention. The lots covered in this recall can be found in the FDA’s recall database.
As noted in the device labeling, possible complications from using the Vascu-Guard patch include dehiscence (wound separation) at the surgical site, which could cause serious bleeding, hematomas, and infection. However, we are concerned about the cluster of bleeding cases that have been reported following CEA so far this year, and are actively investigating possible causes.
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.
See the FDA Safety Alert
See the FDA Letter to Health Care Providers
See also Medical Law Perspectives, September 2016 Report: Stroke: Challenges, Risks, and Liability Issues
See also: Medical Law Perspectives February 2015 Report: Mending a Broken Heart: Malpractice Risks in Diagnosing and Treating Heart Disease
See also: Medical Law Perspectives February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also: Medical Law Perspectives December 2013 Report: Thicker Than Water: Liability When Blood Clots Cause Injury or Death
See also: Medical Law Perspectives November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues
Law practice forms are presented weekly. See forms concerning stroke:
Scalpel Weekly News Premium, Complaint: Stroke Malpractice (August 1, 2016)
Scalpel Weekly News Premium, Expert Affidavit-Stroke (August 8, 2016)
Scalpel Weekly News Premium, Motion: Expert Impeachment and Stroke (August 15, 2016)
Scalpel Weekly News Premium, Striking Stroke Complaint (August 22, 2016)
Scalpel Weekly News Premium, Summary Judgment: Stroke (August 29, 2016)