The Vascu-Guard Patch is a vascular patch manufactured from bovine pericardium that is used to repair peripheral blood vessels. It is also approved for use in arteriovenous access revisions. Vascu-Guard is manufactured by Baxter International, Inc.’s Synovis subsidiary.
The Vascu-Guard Patch was brought to market in 2014. Like many medical devices, it was cleared for sale via the U.S. Food & Drug Administration’s (FDA) 510(K) program, which does not require a manufacturer to conduct human clinical trials of a product if it can be demonstrated that the new device is “substantially equivalent” to another device that has already been approved by the FDA.
According to the Vascu-Guard label, the patch is manufactured from bovine pericardium, which is cross-linked with glutaraldehyde. The pericardium material is sourced from U.S. cattle. Other vascular patches may be made from a saphenous vein or prosthetic patches made out of Dacron or olytetrafluoroethylene.
The Vascu-Guard Patch is approved for use in peripheral vascular reconstruction of the carotid, renal, iliac, femoral, profunda and tibial blood vessels, as well as in arteriovenous access revisions. Complications possibly associated with its use include dehiscence (wound separation) at the surgical site, which can cause serious bleeding, hematomas, and infection.
Since being brought to market, the Vascu-Guard Patch has been named in two serious recalls. The most recent was announced in June 2016, and eventually declared a Class II recall by the FDA. This designation indicates that a product may cause temporary health problems, or pose a slight threat of a serious nature or death.
According to the 2016 Vascu-Guard Patch recall notice, the FDA was investigating reports of severe bleeding and other serious complications that had occurred in patients undergoing carotid endarterectomy (CEA) surgery. CEA eliminates plaque buildup within the carotid artery to prevent heart attack or stroke. The Vascu-Guard Patch is used to repair the artery once the buildup of plaque has been removed.
The reports that prompted this Vascu-Guard recall included intraoperative or postoperative bleeding and hematomas, some of which required additional clinical intervention, and three patient deaths. According to the FDA, arterial bleeding in the neck could rapidly lead to airway obstruction, hypoxia, diminished brain perfusion, stroke and/or cardiac arrest.
A year earlier, the FDA announced a Class I recall for certain Vascu-Guard Patch products that could potentially cause blood clots. According to a recall notice issued in May 2015, a change in packaging had caused the smooth surface of the patch to be too rough, which could result in incorrect implantation of the device. This could allow blood clots to form on the patch, resulting in embolism, reduced blood flow, stroke, organ failure, or death. Baxter had reported 51 complaints related to this issue and one serious injury.
Class I recalls are the most serious type of FDA recall, and are issued when there is a reasonable probability that use of the affected products will cause serious adverse health consequences or death.
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