HeartMate II LVAS Pocket System Controller by Thoratec Corporation: Medical Device Correction - Updated Labeling and Training Materials

• 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 (found on side of each unit)

[Posted 03/05/2014]

AUDIENCE: Cardiology, Surgery, Risk Manager

ISSUE: Thoratec Corporation issued a safety advisory because some patients and caregivers have experienced difficulties with the process of changing from a primary system controller to their backup system controller. These difficulties have resulted in four deaths and five reports of loss of consciousness or other symptoms of hypoperfusion. Of these nine events, 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 occurred in patients who attempted to exchange system controllers while alone and, contrary to the labeling, without contacting the hospital first. The Urgent Medical Device Correction Letter sent to hospitals on March 4, 2014 communicated the reported incident rate over the past year and a half since the introduction of the Pocket System Controller in August 2012.

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

BACKGROUND: The HeartMate II Pocket System Controller can be identified by the catalog number located on the labels of the various packaging configurations.

RECOMMENDATION: Consumers who have the HeartMate II LVAS Pocket Controller should immediately contact their doctor for retraining on use of the device and to receive updated Patient Handbook information.

Physicians who prescribe the HeartMate II LVAS Pocket Controller should immediately review the updated labeling and training materials provided in the Urgent Medical Device Correction Letter with all clinical personnel responsible for training patients and caregivers on the use of the Pocket System Controller. All patients using the Pocket Controller and their caregivers should be retrained on the use of the device and be provided with updated Patient Handbook information.

Hospitals with ongoing HeartMate II LVAS patients using the Pocket System Controller should contact Thoratec at 1-800-528-2577 if they have any questions.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[03/05/2014 - Press Release - Thoratec Corp]