Following the deaths of four people using Thoratec's popular heart pump, the company has issued a warning against improper use of the device. At least two of the deaths have been attributed to misuse.
The HeartMate II Left Ventricular Assist System, a blood-flow regulator, is powered by an external controller. In the cases of those who died, the external controller proved difficult to wrangle, with patients attempting to use the backup control mode instead. In addition, five other patients lost consciousness while similarly trying to use an alternate controller. Of the nine patients, all but one had been educated to use a previous model of the device.
The HeartMate II works by attaching a pump to the heart's left ventricle - or main pumping chamber - thus artificially promoting blood flow. The pump is then connected to a handheld controller through the skin.
A previous model of the HeartMate II was recalled in 2012, when the company uncovered a defect in the mechanics of the device. That particular iteration of the HeartMate was found to have capability to cut blood flow from the pump, leading to possible death.
Notably, the company has not issued a recall of this particular model, indicating that none of the devices involved in the deaths or complications were faulty. Thoratec advised that patients and their carers be better informed on how to use the newer models, suggesting a consultation with their doctors.
"It's a new controller," said Dr. Liviu Klein, a cardiologist at the UCSF Heart and Vascular Center and director of the university's Mechanical Circulatory Support and Heart Failure Device Program to SF Gate. "The blame I don't think falls on the company. It falls on the physicians and the caregivers that did not spend enough time on the patients, did not spend enough time making sure they get the appropriate training."
If you or somebody you care for has a Thoratec device, these are the models the warning applies to:
- HeartMate II Pocket System Controller(model No. 105109)
- HeartMate II Implant Kit with Pocket Controller (#106015, 106016)
- Pocket Controller (#106762, 106017)
- HeartMate II LVAD Pump and Pocket Controller Kit (#107801)