Thoratec Corporation today issued an urgent safety advisory about a serious problem with a key component of the HeartMate II LVAS system. The company said 4 patients had died and 5 patients 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 company said that 8 of the 9 events “occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller. Two of the deaths occurred in patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.”
Thoractec said that their investigation did not uncover any device failures. Patients with the Pocket Controller ”should immediately contact their doctor for retraining on use of the device” and receive an updated patient handbook.
The advisory applies to all HeartMate II LVAS Pocket Controllers, which have been available in Europe since August 2012 and the US and Canada since May 2013. The company said that 2,142 Pocket Controllers have been prescribed, either as original equipment with the HeartMate II LVAD or as a replacement for an older controller. Patients who updated from an older controller are at higher risk for complications because they “may not have received adequate training regarding the differences between the two controllers, especially differences related to the connection of the driveline.”
Last November an article in the New England Journal of Medicine reported a highly troubling increase in pump thrombosis in patients who received the HeartMate II device.