The LVAD device malfunctioned shortly after the patient replaced its batteries, according to the case filed in the FDA’s MAUDE adverse event reporting system.
"This event involves a patient who experienced controller alarms approximately 34 months post HeartWare LVAD implantation and subsequently expired at a local hospital," according to the report. "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 patient was found at home by a family member and taken to a hospital where she died.
HeartWare’s LVAD system includes an implantable pump, external driver and power source that can be used either inside or outside of hospitals. The company in November 2012 won FDA approval to market the device as a so-called "bridge to transplant" for heart failure patients.
The event, logged on February 25, is 1 of a handful of deaths in the MAUDE system associated with HeartWare’s device. Another incident reported for December 18, 2012, involved a patient who died about 4 years after receiving the implant. That patient was also found at home by a family member and taken to an emergency room where he was pronounced dead. A clot was found while doctors were explanting the device during a partial autopsy, according to the report.
The MAUDE database contains about 60 adverse event reports tied to HeartWare in the last 2 years.
HTWR shares fell to $83.87 by the end of the day Friday, along the way sinking briefly to $81.30, a 4.3% drop from an opening price of $84.93. The shares regained that value today, trading at $84.93 as of about 12:10 p.m.