HeartWare International, Inc. (HTWR)

[cjgaddy]

4-5-13: HVAD Malfunction Led to Death, FDA Reports… “After the patient changed the battery in the left ventricular assist device, power dropped and blood flow fell…”

4-5-13: ”HeartWare Device Malfunction Led to Death, FDA Reports”
By Michelle Fay Cortez & Catherine Larkin
http://www.bloomberg.com/news/2013-04-05/heartware-device-malfunction-led-to-death-fda-reports.html

A malfunction in a device from HeartWare International Inc. (HTWR) 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. FDA’s website said. A family member found the woman unresponsive at her house, with the alarm blaring. The problem had persisted for at least 3 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 3 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% to $84.15 at 12:34 p.m. in New York, after decreasing as much as 5.8% 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.