Thoratec Corporation, just issued a global “Urgent Medical Device Correction Letter” as an update to its labeling concerning the use of its HeartMate II® LVAS Pocket System Controller, a medical device, according to a recent U.S. Food and Drug Administration (FDA) announcement.
Thoratec also issued the letter to update training materials on the HeartMate II® LVAS Pocket System Controller. The letter followed some serious, even fatal, difficulties experienced by patients and caregivers.
The pocket controller operates, explained Bloomberg News, a mini heart pump: The HeartMate II LVAS Pocket System Controller helps operate the HeartMate II left ventricular assist device (LVAD), which takes over for the heart in the event of heart failure. The problems occurred when changing from a primary system to a backup system controller, specifically, when changing to a backup controller from the main system, Thoratec said, according to Bloomberg News.
The difficulties led to four patient deaths and five reports of patients losing consciousness or experiencing other symptoms of hypoperfusion (decreased blood flow to an organ). Eight of the nine 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 of the deaths involved patients who had attempted to exchange system controllers while alone. The labeling indicates that the hospital must be contacted firs before attempting this process.
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 Pocket System Controller was introduced in August 2012. Thoratec indicated that its probes into these nine reports did not find that the devices did not meet specifications or suffered from quality control procedure deficiencies.
All patients who use the Pocket Controller, as well as their caregivers, should be re-trained on the use of the device and should be provided with updated Patient Handbook information. Thoratec indicated that 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 receive the updated Patient Handbook information. Physicians who prescribe the HeartMate II LVAS Pocket Controller are also 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 involves all HeartMate II LVAS Pocket Controllers manufactured and distributed, to date, globally. 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 the device was 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 for difficulty in the controller exchange process and may not have received sufficient training on the differences between the two controllers, specifically those differences concerning the driveline.
The HeartMate II Pocket System Controller is identified by the catalog number, which is located on the labels of the various packaging configurations and includes the following device catalog numbers:
- 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)
Hospitals with ongoing HeartMate II LVAS patients who use the Pocket System Controller should contact Thoratec with questions. Clinicians and patients with questions may contact the company, toll-free, at 1.800.528.2577. If calling from outside the U.S., Thoratec may be reached at 1.925-.847.8600, seven days a week, from 8:00 a.m. to 5:00 p.m. Pacific Time.