Thoratec Corp. has issued an urgent safety advisory over four patient deaths related to its HeartMate II left ventricular assist device (LVAD). Five other patients lost consciousness or experienced reduced blood flow when attempting to use backup system controllers for the device.
The Pleasanton, CA–based company is updating labeling and training materials for the HeartMate II LVAS Pocket System Controller because some patients and caregivers experienced difficulties with the process of changing from a primary system controller to their backup system controller.
|HeartMate II, as shown on Thoratec's website|
Besides resulting in four deaths, such difficulties also caused lost consciousness or reduced blood flow for five other patients, Thoratec said in a news release posted on the FDA’s website.
No products need to be returned because the deaths and serious injuries were not the result of device failure, but rather patients and caregivers who were unable to understand instructions.
Of these nine cases of death or serious injury, eight occurred in patients who were converted to the Pocket Controller after being originally trained on an older model, the EPC System Controller. Two of the deaths involved patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first.
|Find out more about the medical device industry—including its technology, supplier networks, and much more—at BIOMEDevice, March 26-27, 2014 in Boston.|
The Pocket Controller has been prescribed for 2,142 patients since its August 2012 European debut; distribution started in the United States and Canada in May 2013.
At 4:24 p.m. ET, the company’s stock was down 2.71%, after sliding $1.01 to $36.22 per share.
Canaccord Genuity analyst Jason Mills states that the problem is likely to have a small impact on Thoratec. To back up that assertion, Mills notes that the adverse event reports were not linked to a device failure per se. In addition, the warning refers to controller rather than the actual LVAD. Finally, he states that the company’s leadership is responding well to the problem.
- How to Develop a Risk Based Biological Safety Evaluation Per New US FDA Guidance - Webcast
- 3 Tips for Successfully Launching an Outsourced Medical Device - Webcast
- When Do I Really Need to Perform an Ethylene Oxide Requalification? - Webcast
- Rapid Prototyping for Medical Devices - Webcast
- New Approaches to Assessing Biocompatibility for Medical Devices - Webcast
- Five Mistakes That Can Derail Your Product Development Effort - Webcast