Thoratec Corp. issued an urgent safety advisory about the use of the pocket controller for its mini heart pump after four patients died and five others were injured.
The notice includes new information and labeling for the HeartMate II LVAS Pocket System Controller prescribed to 2,142 patients since August 2012, Pleasanton, California-based Thoratec said yesterday in a statement. It helps operate the company’s HeartMate II left ventricular assist device, or LVAD, which takes over for a failing heart. Patients and their caregivers encountered problems when changing to a backup controller from their main system, the company said.
About 5.1 million patients are living with heart failure in the U.S., a number that is growing as more people survive heart attacks, high blood pressure and diabetes with irreparable damage. About 20 percent of heart-failure patients die within 12 months and half don’t make it beyond five years. About 5,500 of the LVAD were implanted worldwide in 2012.
Thoratec alerted hospitals about the problems patients and caregivers have experienced changing from a primary system controller to the backup. Two of the deaths occurred when patients tried to change their controller themselves. The five who were injured lost consciousness or suffered from decreased blood flow, the company said.
Thoratec said it didn’t find any flaws with the controllers and it didn’t request their return.
“Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated patient handbook information,” the company said. “All patients using the Pocket Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information.”
Thoratec fell 2.7 percent to $36.22 at the close in New York. The shares have gained 2 percent in the past 12 months.
Patients who got the pocket controller as a replacement for an older model, which works differently, are at a higher risk for encountering problems, the company said. Those patients may not have received enough training with the new machine and failed to understand the differences compared with the old system, Thoratec said.
Eight of the nine incidents occurred in patients who were converted to the pocket controller after being trained on an older model, the company said.