Pleasanton, Calif.-based Thoratec said it sent a worldwide medical device correction letter yesterday after some patients and caregivers had trouble switching from the HeartMate II’s main controller to a backup, according to a press release.
"These difficulties have resulted in 4 deaths and 5 reports of loss of consciousness or other symptoms of hypoperfusion," according to the release.
Eight of the 9 events occurred in patients who were using Thoratec’s pocket controller but had been initially trained to use its older EPC system controller, the medical device company said. Two deaths occurred when patients ignored the HeartMate II’s labeling and, without notifying their hospital, attempted to change controllers alone, according to the release.
"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 company said, noting in a regulatory filing that the warning isn’t expected to affect its finances.
Thoratec won pre-market approval from the FDA for the pocket controller last May, having won CE Mark approval in the European Union in August 2012. Since then, some 2,142 patients have been prescribed with the pocket controller, the company said. Patients who were 1st given an older HeartMate II controller who then switched to the pocket version are "at a higher risk of experiencing difficulty in the controller exchange process," Thoratec said.
"These patients may not have received adequate training regarding the differences between the 2 controllers, especially differences related to the connection of the driveline," according to the release. Thoratec said it’s updated its labeling and training materials for switching controllers.
Thoratec said patients using the pocket controller should contact their physician immediately for retraining and an updated patient handbook. Doctors prescribing the HeartMate II pocket controller should immediately review the training and labeling updates with all clinical person "with all clinical personnel responsible for training patients and caregivers on the use of the pocket system controller" so that patients can be retrained, Thoratec said.
The warning affects the following catalog numbers for the HeartMate II pocket system controller, Thoratec said:
- 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)
THOR shares were off 3.3% at $36 even in pre-market trading today. The stock opened at $36.49 and was down 2.7% to $36.23 as of about 10:10 a.m. today.