FDA MedWatch - HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

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Title: FDA MedWatch - HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

HeartMate II LVAS Pocket System Controller by Abbott-Thoratec: CLass I Recall - Due to Risk of Patient Injury and/or Death during Backup Controller Exchange

AUDIENCE: Cardiology, Risk Manager, Nursing, Patient

ISSUE: Abbott-Thoratec has received a total of 70 reports of incidents in which the controller has malfunctioned after an exchange, including 19 injuries and 26 deaths. All of the deaths occurred when patients attempted to exchange controllers while away from the hospital.

Patients may sometimes need to change to their backup back-up system controller during the course of ventricular assist therapy. The change should be done quickly and in the hospital, because it can present a significant challenge to patients that are elderly and/or untrained. For these patients, a slow or improper driveline changeover places them at risk of serious injury or death.

BACKGROUND: The Pocket System Controller is a power supply that connects to the implanted HeartMate II LVAS pump through a lead (driveline) under the skin. The controller helps power the LVAS system, a mechanical device that circulates blood throughout the body when the heart is too weak to pump blood adequately on its own.

The controller is powered by batteries or connected to a main power supply. The HeartMate II LVAS Pocket System Controller is intended for use inside or outside of the hospital. A back-up system controller is provided to each patient for use in case of a device alarm or malfunction. Instructions and training are provided on how to switch from one system controller to the other. Model/Item Numbers recalled are: 105109, 106015, 106762, 107801 and Manufactured July 2012 to December 2016. The recall was initiated March 30, 2017.

RECOMMENDATION: On March 29, 2017, Abbott-Thoratec sent an "Urgent Medical Device Correction" letter to affected customers. The letter identified the following actions to be taken:

• New HeartMate II LVAS Pocket System Controller patients will receive upgraded hardware and software (to include a fully upgraded system controller with new yellow alignment markings and new lead/driveline) from their ventricular assist device (VAD) coordinator.

• Existing HeartMate II LVAS Pocket System Controller patients will receive updated device software and alarm guides for both their primary and back-up controllers. If existing patients need their controller replaced (if damaged or an old model controller), Abbott-Thoratec will replace the controller at no cost, but thepatient's implanted drive line will not be changed to have matching yellow markings.

• Abbott-Thoratec will contact all affected health care providers to coordinate office visits, and receipt of software updates and updated labeling.

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

• 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.

Please see the complete MedWatch Safety Alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm560222.htm

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