Update to its labeling concerning the use of its HeartMate II LVAS Pocket System Controller. Device maker, Thoratec Corporation, just issued a worldwide “Urgent Medical Device Correction Letter” as an update to its labeling concerning the use of its HeartMate II LVAS Pocket System Controller, according to a recent U.S. Food and Drug Administration (FDA) announcement.
The letter is also meant to update training materials on the HeartMate II LVAS Pocket System Controller and was issued because some patients and caregivers experienced serious, some fatal, difficulties when changing from a primary system controller to a backup system controller.
The pocket controller operates a mini heart pump, Bloomberg News wrote. Specifically, the HeartMate II LVAS Pocket System Controller helps operate the HeartMate II left ventricular assist device (LVAD), which takes over when the heart fails. Patients and caregivers encountered problems when changing to a backup controller from the main system, Thoratec said, according to Bloomberg News.
The difficulties led to four deaths and five reports of loss of consciousness
The difficulties led to four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion (decreased blood flow to an organ) in patients. Eight events involved patients whose treatment was converted to the Pocket Controller after being originally trained on an older model, known as the EPC System Controller. Two deaths involved patients who attempted to exchange system controllers while alone, which is contrary to labeling and which indicates that the hospital must be contacted first.
The “Urgent Medical Device Correction Letter” was sent to hospitals on March 4, 2014 and included the reported incident rate for the past year and a-half since the introduction of the Pocket System Controller, which took place in August 2012. Thoratec indicated that its investigations into these nine reports did not find that the devices did not meet specifications or suffer from deficiencies in quality control procedures.
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. According to the device maker, the products do not need to be returned; however, consumers in possession of the HeartMate II LVAS Pocket Controller should immediately contact their doctor so that they may be re-trained on how to use the device and to also receive updated Patient Handbook information.
Physicians who prescribe the HeartMate II LVAS Pocket Controller are advised to immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter. Review should be conducted with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller.
The Urgent Medical Device Correction Letter applies to all HeartMate II LVAS Pocket Controllers
The Urgent Medical Device Correction Letter applies to all HeartMate II LVAS Pocket Controllers manufactured and distributed, to date, worldwide. Distribution began in the European Union in August 2012, and in the United States and Canada in May 2013. The Pocket Controller has been prescribed to 2,142 patients either at the time the HeartMate II LVAD was implanted, or when prescribed as a replacement for an older System Controller model.
Patients who received the Pocket Controller as a replacement for an older model are at increased risk of experiencing difficulty in the controller exchange process and may not have received sufficient training on the differences between the two controllers, specifically differences related to the driveline.
The HeartMate II Pocket System Controller may 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)