Thoratec Corporation initiated a voluntary worldwide Medical Device Correction in order to update its labelling and training materials for the HeartMate II LVAS Pocket System Controller. This safety advisory is being issued because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller.
These difficulties have resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion. Of these nine events, eight 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 labelling, without contacting the hospital first. The Urgent Medical Device Correction Letter sent to hospitals on March 4, 2014 communicated the reported incident rate over the past year and a half since the introduction of the Pocket System Controller in August 2012.
Thoratec’s investigations of these reports have not revealed any failures of the devices to meet specifications or deficiencies in quality control procedures. No product needs to be returned to Thoratec, a press release reports.
The Urgent Medical Device Correction Letter applies to all HeartMate II LVAS Pocket Controllers manufactured and distributed to date in the United States and worldwide. Distribution was initiated in the European Union in August 2012, and in the United States and Canada in May 2013. The Pocket Controller has been prescribed for 2,142 patients either at the time of the implantation of the HeartMate II LVAD, or as a replacement for an older System Controller model. This latter patient population, those receiving the Pocket Controller as a replacement for an older model, is at a higher risk of experiencing difficulty in the controller exchange process. These patients may not have received adequate training regarding the differences between the two controllers, especially differences related to the connection of the driveline.
Thoratec has informed the US Food and Drug Administration (FDA) and other national competent authorities of this action.