Thoratec HeartMate II Pocket Controllers Linked to Four Deaths

Thoratec has announced that four patients have died and at least five others were injured while trying to switch to a backup controller for their Heartmate II left ventrical assist system (LVAS) by themselves.  

The company issued a worldwide urgent medical device correction letter on Tuesday, to update labeling and training materials for the HeartMate II LVAS Pocket System Controller in response to the problems.

Thoratec notes that of the nine known events, eight happened when patients trained on an older model tried to switch from the main Pocket Controller to a backup.

The Thoratec HeartMate II LVAS is a coronary implant given to patients whose hearts are too weak to efficiently pump blood. Former Vice President Dick Cheney is perhaps the most famous recipient, but they have been widely used among individuals with advanced heart disease who are waiting for a heart transplant or are too weak to undergo such a procedure.

The controllers monitor the HeartMate II and warn patients if the battery charge is running low. The company released a new version of the pocket controller in August 2012 in Europe, and then in May 2013 in the U.S. The company states that 2,142 patients have received the new controller.

Devices affected by the warning include:

• 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

The model number can be found on the side of each pocket controller.

The company’s warning suggests that patients trained on the older model may be having difficulties switching from the main controller to a backup controller if they are now using the newer model. Thoratec states that it does not believe anything is wrong with the device and has decided not to issue a HeartMate II LVAS Pocket System Controller recall.

“Thoratec’s investigations of these reports have not revealed any failures of the devices to meet specifications or deficiencies in quality control procedures,” the company’s letter states. “No product needs to be returned to Thoratec.”

It is likely that the FDA will classify the company’s actions as a Class I medical device recall, considering the deaths and injuries, and the announcement of the company’s warning was flagged as a recall when posted on the FDA’s website. A Class I medical device recall designation is reserved for devices that the agency believes have a high probability of causing severe injuries or death.

The company advises patients with the pocket controller to immediately contact their doctor for retraining on the use of the device and to receive an updated Patient Handbook. The company also advises doctors who prescribe the system to review the updated labeling and training materials.

This is the latest concern surrounding the Thoratec HeartMate II, which has been linked to a potential risk of blood clots in recent months.

A study published in November 2013 highlighted a recent increase in the number of blood clot-related problems with the Thoratec HeartMate II that have been seen since March 2011. After examining data from three different hospitals, researchers from Cleveland Clinic were able to identify that over the past few years there has been an increase in the rate of clot formation during the months after the HeartMate II was implanted, confirming what doctors at the hospital suspected based on their own experiences.

The manufacturer has denied that any changes were made to the device and indicate that the small study does not accurately portray the device’s performance. In January 2014, a Thoratec HeartMate II class action lawsuit was filed by investors who say the company withheld important information about the safety and efficacy of the device, which has caused the stock price to decline.