Thoratec HeartMate II Controller Warning Updated

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Device maker, Thoratec, just updated its warning concerning the risks associated with switching controllers for its HeartMate II implantable heart pump.

The Thoratec HeartMate II left ventricular assist device (LVAD) has been associated with nine reports that include eight serious injuries and deaths, according to MassDevice.com. The problem originates with a “[f]ailure to completely connect the driveline during the process of exchanging pocket system controllers,” according to Thoratec. The issue is riskier for those patients who previously used an older controller model and then tried 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 announced. As of February 4, the rate of serious injury or death was 1.5 percent or eight out of every 523 patients for those patients who converted from the older controller to the pocket model, Thoratec indicated. The rate was 0.1 percent, or one out of 1,619, for those patients who switched from one pocket controller to another pocket controller, according to Thoratec.

At the time of Thoratec’s prior warning, which was issued earlier this month, the device maker cited reports involving four deaths and five cases in which patients lost consciousness or experienced other symptoms of hypoperfusion. Eight events involved patients using Thoratec’s pocket controller who had been initially trained to use the older EPC system controller, Thoratec indicated. Two deaths took place when patients did not heed the HeartMate II’s labeling and, without notifying their hospital, attempted to change their controllers without assistance.

The prior, global “Urgent Medical Device Correction Letter” was issued as an update to its labeling and training materials for the HeartMate II LVAS
Pocket System Controller, according to a recent U.S. Food and Drug Administration (FDA) announcement.

Thoratec received pre-market FDA approval for the pocket controller last May and also won CE Mark approval in the European Union in August 2012. Since, some 2,142 patients have been prescribed with the pocket controller, according to MassDevice.com.

Bloomberg News previously wrote that the pocket controller operates a mini heart pump: The HeartMate II LVAS Pocket System Controller helps operate the HeartMate II left ventricular assist device (LVAD). The device takes over for the heart in the event of heart failure. Problems occurred when changing from a primary system to a backup system controller, specifically, when changing to a backup controller from the main system, according to Thoratec, wrote Bloomberg News.

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. “No product needs to be returned to Thoratec,” the company indicated, according to MassDevice.com.

Patients who use the Pocket Controller, and their caregivers, should be re-trained on the use of the device and should be provided with updated Patient Handbook information. Thoratec indicated that 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.