Reporting adverse events involving medical devices. HeartWare International, a Florida medical device maker, saw its stock price drop on Friday, as investors reacted to news of the death of a patient implanted with the company’s left ventricular assistive device (LVAD).
A report was filed on February 26, 2013, with the U.S. Food and Drug Administration (FDA)’s MAUDE system, Mass Device said. MAUDE, which stands for “Manufacturer and User Facility Device Database,” is the FDA’s system for reporting adverse events involving medical devices.
The patient described in the report had received a HeartWare LVAD implant about 34 months earlier. She was found at home by a family member and taken to a hospital, where she died, Mass Device said. According to the MAUDE report, shortly after changing the device’s batteries, “the patient experienced a controller fault alarm followed by a sustained drop in flow and power.” The FDA said that the device has been returned to the manufacturer for evaluation.
HeartWare’s LVAD system includes an implantable pump, external driver, and power source. It can be used either in or out of a hospital, Mass Device says. LVADs assist hearts too weak to pump effectively on their own. In November 2012, HeartWare received FDA approval to market its ventricular assist system as a “bridge to transplant” for heart failure patients.
According to Mass Device, the February death is one of a handful of deaths associated with the HeartWare device in the MAUDE system. A similar incident in December 2012 involved a patient who died about four years after receiving the implant. That patient was also found by a family member and taken to an emergency room, where he was pronounced dead. The MAUDE report said that doctors found a clot when removing the device during a partial autopsy.
The MAUDE database contains about 60 adverse event reports tied to HeartWare in the last two years, Mass Device said.
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