Heart assist device company Thoratec Corporation has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for the HeartMate II® LVAS Pocket System Controller. The advisory follows four deaths among patients while initiating switches of controller
While Thoratec says its investigations have not revealed any failures of the devices to meet specifications or deficiencies in quality control procedures, the company also accepts 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. 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. 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.
Supporting its claim that there is no fundamental system problem, the company is not requesting return of any units or component. That said, consumers who have the HeartMate II LVAS Pocket Controller have been instructed to immediately contact their doctor for retraining on use of the device and to receive updated Patient Handbook information.
As far as prescribing physicians are concerned, they are instructed to 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. Furthermore 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 HeartMate II Pocket System Controller can be identified by the catalog number located on the labels of the various packaging configurations. The following device catalog numbers are affected by this action:
HeartMate II Implant Kit with Pocket Controller: Catalog Numbers 106015 and 106016
Pocket Controller: Catalog Numbers 106762 and 106017
HeartMate II LVAD Pump and Pocket Controller Kit: Catalog Number 107801
Pocket Controllers that have been removed from packaging: Model Number 105109 (found on side of each unit)
Source: Thoratec Corporation., PR Newswire