Thoratec Corporation of Pleasanton has initiated a voluntary worldwide Medical Device Correction in order to update its labeling and training materials for its HeartMate II) LVAS Pocket System Controller.
The safety advisory was issued because some patients and caregivers had experienced difficulties with the process of changing from a primary system controller to their backup system controller. Those difficulties resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion.
"Failure to completely connect the driveline during the process of exchanging Pocket System Controllers has resulted in serious injuries and deaths," a Thoratec spokesman said.
"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," the spokesman added.
As of Feb. 4, 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%, while the rate for patients who received the Pocket Controller at the time of implant was 0.1%.
Of the nine incidences, 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 communicated the reported incident rate over the past year and a half since the introduction of the Pocket System Controller in August 2012.
Thoratec said its 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.
Consumers who have 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.
The company also urged physicians who prescribe the Pocket Controller to 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.
Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).
Thoratec has informed the FDA and other national competent authorities of this action. n