Vascu-Guard Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

UPDATED 07/06/2017. Following Baxter International, Inc.’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, and we have not been notified of any new events related to this issue since issuing the September 1, 2016 letter to health care providers.

Baxter’s voluntary recall closed on June 23, 2017. The FDA continues to recommend that health care providers discuss with their patients all available treatment options for CEA surgery, including their benefits and risks, before deciding the best treatment approach. Health care providers should also continue to report all adverse events related to the Vascu-Guard Peripheral Vascular Patch through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices.

[Posted 09/01/2016]

AUDIENCE: Surgery, Risk Manager

ISSUE: The FDA 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). 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 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.

BACKGROUND: 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.

RECOMMENDATION: The FDA recommends that health care providers:

• Discuss with your patients all available treatment options, including the risks and benefits of each, before deciding the best treatment approach.
• Until FDA completes its investigation of the adverse events reported following CEA surgery, consider the following actions if using this device:
  • Employ heightened post-operative vigilance on the part of the patient and physician for signs of early bleeding (e.g., neck swelling, difficulty breathing).
  • Follow all manufacturer instructions for patch preparation.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[07/06/2017 - Update Regarding Investigation of Reported Adverse Events - FDA]
[09/01/2016 - Letter to Health Care Providers - FDA]