Heartware Device Malfunction Raises Safety Concerns

A malfunction in a heart assist device developed by HeartWare International Inc. has led to a patient’s death. HeartWare won FDA approval to market its left ventricular assist device (LVAD) in November 2012 for patients who have been diagnosed with end-stage heart failure awaiting a heart transplant.

The malfunction was captured by the U.S. Food and Drug Administration’s MAUDE (Manufacturer and User facility Device Experience) reporting system. It involved a patient who, after changing the batteries in the device, experienced a power and blood flow drop that set off alarms. A family member found the woman unresponsive three hours later. She was rushed to a local hospital where she subsequently died. The device, which had been implanted in the woman 34 months earlier, was sent to the FDA for analysis.

HeartWare took voluntary action in February 2013 to address an unrelated issue involving the device’s driveline connector housing, advising healthcare professionals to inspect it during regular patient visits. According to the company, none of the 11 confirmed events related to the connector housing had caused harm to patients.

FDA approval of the device was based on data gathered from a clinical test, ADVANCE trial that tracked similarly diagnosed patients. The test group received the HeartWare LVAD while the control group had received the Thoratec HeartMate II implant. Surgical outcomes were comparable between the two groups in the trial. When announcing the device’s acceptance, the FDA said it was the first time an LVAD had been approved based on registry data as a control.

HeartWare said the FDA was requiring it to perform a 1,200 person follow-up study to verify the initial findings. As with the original test, the study consists of an equal mix of HeartWare patients and control patients. It is expected to be completed in 2018. The FDA also announced that it will require training with an approved program for those sites that intend to implant the device.