The HeartMate II by Thoratec Corporation and HeartWare by HeartWare have been linked with serious adverse events including increased rate of pump thrombosis (blood clots inside the pump) with Thoratec’s HeartMate II and a high rate of stroke with the HeartWare device, reports the FDA. Bleeding complications have also been linked to the devices.
The HeartMate II was approved in 2008 for use as a bridge to transplant (BTT) for patients at risk of imminent death due to nonreversible left ventricle heart failure, says Medpage Today. The device was then approved for use as destination therapy for patients who are not candidates to receive donor hearts in 2010. The HeartWare system was approved for use only as a BTT in 2012.
The FDA is now receiving reports of pump thrombosis earlier than observed during clinical trials in patients with the HeartMate II. Risk is highest around 3 months after implant, according to studies. The FDA will also be issuing a safety warning after reviewing study results linking the HeartWare product to increased risk of stroke.
The FDA is working with both manufacturers on new labeling and safety warnings. The agency notes that in the case of HeartWare as a bridge to transplant option, the benefit of the device is believed to outweigh the risk of stroke.
The FDA advises physicians to take extra precautions before implanting either device and asks that all explanted products and components be returned to the manufacturers.