Abbott is communicating to physicians about a field corrective action related to the HeartMate 3 Left Ventricular Assist Device, according to a statement on the FDA’s website. Abbott notified physicians and global regulatory bodies on April 5, 2018, that outflow graft twisting could occur post-implant in the HeartMate 3 LVAD, resulting in a persistent low flow alarm that may signal a potential safety risk to patients, such as low blood flow or clotting. No devices are being recalled from patients or hospitals as a result of the corrective action, and the recommendations made by Abbott remain in place for physicians managing patients implanted with HeartMate 3. Abbott is currently aware of 32 reports of outflow graft twisting in 4,467 HeartMate 3 devices worldwide, including reports of low blood flow, clotting, and three reported deaths that could be associated with outflow graft twisting. As a result, Abbott has contacted physicians managing patients implanted with a HeartMate 3 LVAD in the event their patients report persistent low flow alarms that could indicate outflow graft twisting. Twisting of the outflow graft can occur at any point after implant.
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