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Thoratec issues urgent labeling correction for HeartMate II LVAD controller
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Thoratec Corp. has issued a worldwide Medical Device Correction to update the labeling and training materials for the HeartMate II LVAS Pocket System Controller, after difficulties with the process of changing from the primary system controller to the backup controller resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion.
The company stated that its investigations did not indicate any device failures or deficiencies in quality control, and that no devices need to be returned. In eight of the nine reported cases, the patients had been converted to the HeartMate II LVAS Pocket Controller after being trained on an older model, the EPC System Controller, according to a press release.
Physicians prescribing the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with anyone who trains patients and caregivers on how to use the device, according to the company’s safety advisory. Patients and caregivers using the device should contact their doctor for retraining and updated patient handbook information, the company stated.
The advisory was posted on the FDA’s Recalls, Market Withdrawals, & Safety Alerts page.
The HeartMate II LVAS Pocket Controller was introduced in Europe during August 2012 and in the United States and Canada in May 2013. The device has been prescribed for 2,142 patients at the time of implantation of the HeartMate II left ventricular assist device (LVAD) or as a replacement for an older controller model, according to the release.