4 Deaths Linked to HeartMate II Left Ventricular Assist Device — Physician’s First Watch
4 Deaths Linked to HeartMate II Left Ventricular Assist Device
By Larry Husten
Thoratec Corporation issued on Tuesday an urgent safety advisory about a serious problem with a key component of the HeartMate II left ventricular assist device. The company said four patients died and five had a loss of consciousness or other symptoms of hypoperfusion. The episodes occurred when patients and caregivers "experienced difficulties with the process of changing from a primary system controller to their backup system controller."
The advisory applies to all HeartMate II LVAS Pocket Controllers, which have been available in the U.S. since May 2013.
Thoratec said their investigation did not uncover any device failures. Eight of the nine events "occurred in patients who were converted to the Pocket Controller after being originally trained on an older model." Patients with the Pocket Controller should contact their doctor immediately for retraining.
Adapted from CardioExchange