FDA: Woman with HeartWare HVAD dies after device loses power

Less than 6 months after gaining FDA approval for its game-changing HVAD heart pump, HeartWare International ($HTWR) is facing reports of another mechanical problem. And this time, a patient died.

The FDA issued an adverse event report for the incident, which took place on Feb. 25, 2013. Regulators note that an unidentified female patient had had the implant for nearly three years, at which point she changed the batteries. The device's controller fault alarm went off and then lost much of its juice and blood flow fell, regulators explain. Three hours later, a family member found the woman unresponsive. After emergency workers briefly revived her, she was taken to a hospital, where she died a short time later, according to the FDA.

It is unclear at this point what caused the malfunction, though the device has been returned to HeartWare for evaluation. Bloomberg reports that autopsy reports haven't been released yet, and that a company spokesperson didn't respond to requests for comment. The device is a minipump designed to help save heart failure patients waiting for a transplant and has had a CE mark since 2009. HeartWare won FDA approval just last November.

Earlier in February, HeartWare disclosed that at least 11 of 2,900 HVAD heart pump implants developed a mechanical problem where a part could become partially separated from the main unit after extended use. HeartWare pursued a "voluntary field correction" to make sure the breakdown wasn't more widespread, and at that point, had no reports of any health problems based on that particular malfunction.

- read the FDA report
- here's Bloomberg's take