Four Thoratec heart pump patients die after struggling with backup controllers

Thoratec's HeartMate II left ventricular assist device--Courtesy of Thoratec

Four patients died and 5 others faced brief scares due to problems involving a device used with Thoratec's ($THOR) HeartMate pumps. The snafus could create a significant challenge for the California company, which has largely relied on this single product line for much of its recent growth and success. Perception can be everything, and trouble can tarnish a product's reputation and scare customers away if it isn't rapidly addressed.

The Wall Street Journal reported that the problems involved some patients with Thoratec's HeartMate II left ventricular assist device implants who struggled to switch to backup system controllers. That process is necessary when an external battery pack runs low, after which the system controller notifies the patient about a need for backup. Thoratec issued a safety advisory to hospitals earlier this week, according to the story, noting that four patients died while trying to switch to the backup system controller, and 5 others either became unconscious or saw their blood flow dip because of the same problem.

All but one of the incidents involved a new system controller that Thoratec started selling in the U.S. last May and in August 2012 in Europe, The Wall Street Journal noted. Thoratec warned that patients using the new controller who were trained with an older version had a greater risk of problems in switching to the backup system. The company cautioned that patients and their caregivers needed additional training to better understand the product differences.

Thoratec explained in its safety advisory that two patients died while trying to change system controllers on their own without first contacting the hospital, which is stipulated in labeling. Overall, 2,142 HeartMate II patients have been given the new system controller outright or had their older system replaced with the new model, Thoratec said, according to the story.

HeartMate's rapid revenue growth has been slowing. Thoratec said it booked $128.2 million in net revenue in its 2013 fourth quarter, essentially flat compared to the same period last year. Net income hit $13.1 million, versus a $14.4 million loss in 2012 Q4. For the year, revenues reached $502.8 million, just a 2% increase over the $491.7 million generated in 2012.

Thoratec traded at $36.21 late morning on March 5, down 2.74%.

- read the WSJ story (sub. req.)

Suggested Articles

The FDA has cleared its first fully disposable duodenoscope, following years of reports of infections being transmitted between patients.

OR-focused AI provider Caresyntax has garnered $45.6 million in new funding and picked up a data analytics firm to broaden its footprint.

A study of Foundation Medicine’s FoundationOne liquid biopsy test found it was able to predict the risk that a person’s breast cancer would return.