BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 4529214 · Received February 20, 2015

    Report

    Report Number
    2916596-2015-00316
    Event Type
    Death
    Date Received
    February 20, 2015
    Date of Event
    April 28, 2014
    Report Date
    January 23, 2015
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE: 2 MO. THE REFERENCED PUMP EXCHANGE WAS REPORTED UNDER MEDWATCH MFR# 2916596-2014-00434. THE DEVICE WAS NOT EXPLANTED. NO FURTHER INFORMATION IS AVAILABLE. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    CORRECTED INFORMATION: A CORRELATION BETWEEN THE LVAD AND THE REPORTED STROKE COULD NOT BE CONCLUSIVELY DETERMINED AS THE PUMP WAS NOT RETURNED FOR EVALUATION; HOWEVER, STROKE IS LISTED IN THE HEARTMATE II INSTRUCTIONS FOR USE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. THE PATIENT UNDERWENT A PUMP EXCHANGE ON (B)(6) 2014 DUE TO A DRIVELINE INFECTION. IT WAS REPORTED THAT THE PATIENT EXPERIENCED A STROKE TWO DAYS POST PUMP EXCHANGE. APPROXIMATELY TWO MONTHS LATER, SUPPORT WAS WITHDRAWN AND THE PATIENT EXPIRED ON (B)(6) 2014. THE DEVICE WAS OPERATING WITHIN NORMAL LIMITS. NO HEMOLYSIS OR SUSPECTED THROMBUS WAS REPORTED. THE PUMP WAS NOT EXPLANTED AND AN AUTOPSY WAS NOT PERFORMED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION INDICATED THAT THERE WAS A CORRECTION TO EVENT DETAILS: ACCORDING TO THE VAD COORDINATOR, THE PATIENT HAD A STROKE ON (B)(6) 2014, THREE DAYS POST PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    121014 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Death