Thoratec (NSDQ:THOR) issued an update about a problem with its HeartMate II left ventricular assist device involved in 8 serious injuries or deaths.
Pleasanton, Calif.-based Thoratec said the problem, stemming from "[f]ailure to completely connect the driveline during the process of exchanging pocket system controllers," is riskier for patients who started out with an older controller model and then attempted to upgrade to the newer pocket controller.
"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 2 controller models, especially differences related to the connection of the driveline," Thoratec said.
The rate of serious injury or death as of Feb. 4 was 1.5% (8 out of 523) for patients converting from the older controller to the pocket model, according to a press release. The rate was 0.1% (1 out of 1,619) for patients switching from 1 pocket controller to another pocket controller, according to the release.
When Thoratec issued its initial warning earlier this month, it cited reports of 4 deaths and 5 incidences of loss of consciousness or other symptoms of hypoperfusion. Eight of those 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," the company said, adding that it’s updated its labeling and training materials for switching controllers.
Patients using the pocket controller should contact their physician immediately for retraining and an updated patient handbook, Thoratec said. 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, the company said.
THOR shares were trading at $36.62 apiece as of about 10 a.m. today, up 4.6%.
