A case filed in the U.S. Food and Drug Administration’s MAUDE (Manufacturer And User facility Device Experience) adverse event reporting system reveals a patient death associated with a HeartWare International’s left ventricular assist device (LVAD).
HeartWare’s VLAD malfunctioned after a patient replaced its batteries, said MassDevice, citing the case filed in FDA’s MAUDE system.
“This event involves a patient who experienced controller alarms approximately 34 months post HeartWare LVAD implantation and subsequently expired at a local hospital,” the report stated. “A preliminary log file analysis revealed that shortly after changing her batteries, the patient experienced a controller fault alarm followed by a sustained drop in flow and power,” the report continued, said MassDevice.
The patient was discovered at home by a member of her family and was taken to the hospital, where she died.
The LVAD system includes an implantable pump, an external driver, and a power source that is usable in and outside of a hospital setting. The system won FDA approval in November 2012 to market the VLAD as a “bridge to transplant” for heart failure patients, MassDevice explained.
The event was logged into the MAUDE system along with what MassDevice described as a “handful of deaths” in the system that have been associated with HeartWare’s LVAD device. A prior incident was reported on December 18, 2012 and involved a patient who died four years after being implanted with the HeartWare VLAD. In that case, the patient was also found at home by a member of his family and was taken to the emergency room. He was pronounced dead at the hospital, said MassDevice. According to the report, the partial autopsy revealed a clot was discovered when doctors were explanting—removing—the device.
Over the past two years, the MAUDE database has received some 60 adverse event reports associated with HeartWare, said MassDevice.
When the HeartWare LVAD was approved, Cardiology Today, described it as an LVAD meant to support heart function and blood flow in patients diagnosed with end-stage heart failure and who are awaiting a heart transplant.
The FDA based approval of the HeartWare LVAD on data from the ADVANCE trial (Action in Diabetes and Vascular Disease: Preterax and Diamicron MR Controlled Evaluation). The trial compared outcomes from 137 advanced heart failure patients who were using the HeartWare System to outcomes from similarly diagnosed patients who were followed by the Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS), said Cardiology Today.
The FDA Circulatory System Devices Panel of the Medical Devices Advisory Committee recommend approval of the device in a 9-2 vote. Approval of the device marked the first time the FDA approved an LVAD using registry data as a trial control, Cardiology Today pointed out.