After Baxter International, Incorporated’s voluntary recall that was issued on June 24, 2016, the U.S. Food and Drug Administration (FDA) has joined the manufacturer to evaluate the severe bleeding and hematoma events reported following carotid endarterectomy (CEA) surgery. A hematoma is an abnormal collection of blood outside of a blood vessel.
At this time, the FDA has not yet identified an initial cause of the aforementioned bleeding events, and the agency has not been notified of any new events related to this issue since the September 1, 2016 letter to healthcare providers, according to the FDA website.
The voluntary recall initiated by Baxter, closed on June 23, 2017. The FDA continues to advise healthcare providers to weigh all available treatment options for CEA surgery with their patients, including the benefits and risks, before deciding which treatment approach would be best. Healthcare providers should continue to report any and all adverse events involving the Vascu-Guard Peripheral Vascular Patch through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Prompt reporting of adverse events aids the FDA in identifying and better understanding the risks connected to medical devices.
2016 Warning Notice
The FDA released a notice warning of issues with Baxter’s Vascu-Guard peripheral vascular patch in September 2016, after receiving multiple adverse event reports including three patients’ deaths potentially linked to the issue.
The Vascu-Guard patch is meant for use in vascular reconstruction surgeries including carotid, renal, iliac, femoral, profund, and tibial blood vessels and arteriovenous access revisions, the FDA said.
The federal agency said it had received reports of issues with intraoperative (during surgery) or postoperative bleeding and hematomas, some of which necessitated clinical interventions, and three patient deaths which occurred shortly after carotid endarterectomy procedures.
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At the time, the FDA said it 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,” according to the agency’s safety notice.
The FDA notes, after CEA surgery in particular, arterial bleeding in the neck, could cause airway obstruction, diminished brain perfusion (cerebral blood flow), hypoxia (oxygen deficiency), stroke, or cardiac arrest. The agency recommends that healthcare providers who work with the patch discuss treatment options with patients and “employ heightened post-operative vigilance” to watch for signs of early bleeding, reports MassDevice.
The FDA said it had been working with the company since it initiated a voluntary recall of certain lots of the patches in June, which the agency designated as a Class II recall in August.
Examining the Problem
The Vascu-Guard patch is designed for use in peripheral vascular reconstruction including various blood vessels and arteriovenous access revisions. Patients with obstructive (atherosclerotic) or aneurysmal peripheral vascular disease who require surgical reconstruction may be exposed to this device, as could patients undergoing surgery on the carotid, renal, iliac, femoral, profundal, and tibial arteries. While this product may be used in other areas of the body, the FDA is aware of adverse events post-CEA surgery.
Additional vascular patches include those made out of Dacron or polytetrafluoroethylene (PTFE) or pieces of a saphenous vein, either of two main superficial (near the surface) veins of the leg. One vein originates in the foot and passes up the medial side of the leg (called the great saphenous vein), and the other, originates similarly and passes up the back of the leg (the small saphenous vein).
June 2016 Safety Alert
In June 2016, Baxter International, Inc. sent a safety alert to its customers, voluntarily recalling specific lots of the Vascu-Guard patch due to reports of intraoperative or postoperative bleeding and hematomas following CEA surgery
In the device labeling, it is noted that possible complications from using the Vascu-Guard patch could include dehiscence (wound separation) at the surgical site, which may cause serious bleeding, hematomas, and infection. The FDA was concerned about the cluster of bleeding cases that had been reported following CEA and are actively investigating possible causes.
The FDA recommends that post-operative vigilance on the part of the patient as well as the physician can be critical for signs, (such as neck swelling, difficulty breathing), of early bleeding.
Legal Information Regarding Injury from a Medical Device
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