Thoratec is updating the warning for its recalled HeartMate II left ventricular assist device, which has been linked to eight deaths or serious injuries. According to Mass Device, the company updated its warning to say that patients who first had an older controller and then switched to the pocket controller were exposed to greater risks. The company said that the issue is attributed to “[f]ailure to completely connect the driveline during the process of exchanging pocket system controllers,” carries a greater risk for patients who originally had an older controller model and then tried to upgrade to the newer pocket controller.
“Patients who received the pocket controller as a replacement for an older model (EPC system controller) may be at a higher risk of experiencing difficulty in the controller exchange process, as there are differences between the 2 controller models, especially differences related to the connection of the driveline,” said Thoratec.
In a press release, Thoratec said the rate of serious injury or death associated with the device was 1.5 percent, (8 out of 523) for patients that switch from an older controller to the pocket model. For patients switching from 1 pocket controller to another, the rate is 0.1 percent.
The recall was initially issued earlier this month. At the time, 4 deaths and 5 incidences of loss of consciousness or other signs of hypoperfusion were reported. Thoratec said that eight of the nine cases had been initially trained to use its older EPC system but were using the pocket controller.
Thoratec received premarket approval for the pocket controller last May. Over 2,000 patients have been prescribed the device since that time. The company said that people were “at a higher risk of experiencing difficulty in the controller exchange process,” if they were first given an older HeartMate II controller and then switched over to the pocket version.