HeartWare Device Malfunction Led to Death, FDA Reports

A malfunction in a device from HeartWare International Inc. used to take over the heart’s beating action led to a patient death, U.S. regulators said. The company’s shares declined.

After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell, setting off a controller fault alarm, the report posted on the U.S. Food and Drug Administration’s website said. A family member found the woman unresponsive at her house, with the alarm blaring. The problem had persisted for at least three hours before it was addressed, according to a preliminary analysis.

The patient, who was unidentified in the FDA report, was taken to a local hospital, where she died. She had had the device for nearly three years before the malfunction, which occurred on Feb. 25, the FDA said.

The death may increase safety concerns if the problem is shown to be a malfunction related to the actual device, Bloomberg Industries analyst Jason McGorman said in an interview. It’s not clear from the FDA report what caused the device to stop working correctly.

HeartWare fell 2.5 percent to $84.15 at 12:34 p.m. in New York, after decreasing as much as 5.8 percent for the biggest intraday drop since Nov. 27. Christopher Taylor, a HeartWare spokesman, didn’t return a phone call or e-mail seeking comment.

The device was returned to HeartWare, based in Framingham, Massachusetts, the agency said. An autopsy was done, though the results haven’t been provided.

Before it's here, it's on the Bloomberg Terminal.