Federal health regulators have warned that Baxter International, Inc.’s Vascu-Guard Peripheral Vascular Patch may cause internal bleeding and other dangerous complications. Individuals who experienced life-threatening bleeding, blood clots, hematoma, embolisms or stroke following such a procedure may be eligible to pursue financial compensation via a Vascu-Guard Patch lawsuit.
Bernstein Liebhard LLP, a nationwide law firm that provides legal representation to victims of defective drugs and medical devices, is offering free legal reviews to possible victims of Vascu-Guard Patch complications, including:
To learn more about filing a Vascu-Guard Patch lawsuit, please contact our Firm today by calling (888) 994-5118.
Baxter International’s Vascu-Guard Patch is designed for use in peripheral vascular reconstruction and arteriovenous access revisions. The U.S. Food & Drug Administration (FDA) cleared the product for sale in November 2014, via its 510(k) process. This clearance protocol does not require that a medical device undergo human testing if a manufacturer can demonstrate that it is substantially equivalent to another product previously approved by the agency.
In September 2016, the FDA disclosed that it had received multiple reports of adverse events associated with the use of the Vascu-Guard Patch in carotid endarterectomy (CEA) surgery. According to the agency, a number of incidents involving intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, were reported by Baxter in 2016. Three patient deaths that occurred shortly after a CEA procedure may also be related to this issue.
“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,” the agency’s September 1st alert warned. “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.”
Baxter International instituted a Vascu-Guard Patch recall for select lots of the product in June 2016, and the company said that it was working with the FDA to determine whether the action covered all lots that could be associated with similar adverse events. The agency has designated the action a Class II recall, which indicates that the affected Vascu-Guard Patches might cause a temporary health problem, or pose a slight threat of a serious nature or death.
The 2016 action marked the second time Baxter International had recalled Vascu-Guard Patch products. A year earlier, the company announced a recall involving four product codes, after customers complained of difficulty in distinguishing the smooth from rough surface of the patch as described in the labeled instructions for use. Incorrect orientation of the patch with the rough side toward the bloodstream can increase the risk of vessel thrombosis (blood clot) and/or embolism, and Baxter acknowledged receiving a number of such reports that involved affected product codes.
This recall was categorized as Class I by the FDA. This is the agency’s most serious class of recall, and indicates that there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Patients who suffered serious complications following surgery with Baxter International’s Vascu-Guard Patch, or their surviving family members, may be entitled to financial compensation for injury-related damages, including:
To learn more about filing a Vascu-Guard Patch lawsuit, please contact the medical device attorneys at Bernstein Liebhard LLP by calling (888) 994-5118.
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