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FDA Warns Surgeons Three Deaths are Potentially Related to Vascu-Guard Patch

By Burg Simpson
September 2, 2016
2 min read

The United States Food and Drug Administration (“FDA”) has issued a letter to surgeons warning them about three deaths “potentially” related to Baxter International Incorporated’s Vascu-Guard Peripheral Vascular Patch.  The FDA cautioned surgeons in this letter that the Vascu-Guard patch may not be performing as intended during carotid endarterectomy (“CEA”) procedures, leading to serious adverse health consequences such as severe bleeding, hematomas, and death.  CEA surgery is often performed when a person has high levels of plaque in their neck, or carotid, arteries.  This plaque can limit blood flow to a person’s brain, and can lead to blood clots or strokes.

The Vascu-Guard patch is used for peripheral vascular reconstruction, and can be used in many procedures where arterial reconstruction is required.  The FDA is particularly concerned with arterial bleeding after CEA surgery because “arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke, and/or cardiac arrest.”

This is not the first time that the Vascu-Guard patch has caused problems.  Baxter issued a Class I recall, the most serious type of recall, of certain Vascu-Guard patch lots last year because blood clots could form on these patches if they were implanted incorrectly.  The lots covered by that recall can be found here.[1]  Baxter also issued a safety alert voluntarily recalling specific lots of Vascu-Guard patches on August 12, 2016.  The lots covered in that recall can be found here,[2] and the FDA is currently working with Baxter to determine if unrecalled Vascu-Guard lots may have similar problems to the ones that were recalled.

If you or a loved one suffered injuries that you believe were caused by a Vascu-Guard patch manufactured by Baxter International Incorporated, contact one of the experienced medical device attorneys at Burg Simpson today.  Our award-winning lawyers would be happy to discuss your potential claim.  Call 1-800-713-9340 or fill out our contact form for a FREE no-obligation consultation today.

[1] http://www.fda.gov/MedicalDevices/Safety/ListofRecalls/ucm449825.htm

[2] http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?id=148062.

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