A safety advisory was released by Thoratec Corp. regarding the use of the pocket controller for its mini heart pump after four patients died and five other patients suffered injury.
Also included in the safety advisory is updated information and labeling for the HeartMate II LVAS Pocket System Controller that has been prescribed to more than 2,100 patients since August 2012.
Patients who updated from an older controller are at a higher risk of complications, because they may not have received adequate training regarding the differences between the two controllers. Two of the deaths occurred when patients tried to change the controller themselves, at home while alone and without notifying the hospital as told. The five injured patients lost consciousness or suffered from decreased blood flow.
In the U.S., there is an estimated 5.1 million people living with heart failure, and that number is increasing as more people survive heart attacks, high blood pressure and diabetes with irreparable damage. Twenty-percent of patients with heart failure die within 12 months, and half don’t make it beyond five years.
Patients with the controller should contact their doctor immediately for retraining on use of the device” and receive an updated patient handbook.