FDA MedWatch - VASCU-GUARD Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

["FDA MedWatch" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: FDA MedWatch - VASCU-GUARD Peripheral Vascular Patch by Baxter International: Letter to Health Care Providers - Potential Risk of Severe Bleeding and Hematomas

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

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

Read the MedWatch safety alert, including a link to the Letter to Healthcare Providers, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm518852.htm

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You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

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