A couple of weeks ago we reported the news of Thoratec Corporation’s voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS (Left Venrticular Assist System)Pocket System Controller. Now the company has issued further information in support of its original notice.
To precis what Thoratec was saying a few weeks ago, it doesn’t believe its devices fail to meet specifications. Indeed the company is not requesting return of any units or component. It does however accept that 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.
So to the new information: Thoratec is clarifying its position by saying that failure to completely connect the driveline during the process of exchanging Pocket System Controllers has resulted in serious injuries and deaths. Specifically, 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 two controller models, especially differences related to the connection of the driveline.
As of February 4, 2014, the rate of serious injury or death during the process of controller exchange for patients who converted to the Pocket Controller from the EPC Controller was 1.5% (8/523), while the rate for patients who received the Pocket Controller at the time of implant was 0.1% (1/1619).
So what to do? In its new release, Thoratec is reinforcing the guidance that patients who are using 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 if they have not been contacted by their doctor already.
Pocket Controllers can be identified by the following model information that shows on the label on the controller: REF 105109.
Source: Thoratec Corporation, PR Newswire