Thoratec Corporation initiated a worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II LVAS Pocket System Controller (the “Pocket Controller”). This safety advisory was 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 labeling, without contacting the hospital first.
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.
The HeartMate II LVAS Pocket System Controller is part of a first-line intermediate-to-chronic left ventricular assist system. This system provides several years of circulatory support for advanced heart failure patients.
Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller. 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.
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.
See the Recall
See also Medical Law Perspectives, February 2014 Report: Congenital Heart Conditions: How Infants, Adults, and Healthcare Providers Handle the Risks
See also Medical Law Perspectives, November 2013 Report: Diagnosis and Treatment of Heart Attacks: Liability Issues