BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6985658 · Received October 27, 2017

    Report

    Report Number
    2916596-2017-02517
    Event Type
    Death
    Date Received
    October 27, 2017
    Date of Event
    October 2, 2017
    Report Date
    December 12, 2017
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT¿S AGE AND WEIGHT WERE NOT PROVIDED. (B)(4). APPROXIMATE AGE OF DEVICE ¿ 5 YEARS AND 3 MONTHS. THE PUMP WAS NOT RETURNED FOR EVALUATION AS IT WAS NOT EXPLANTED. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED AND WAS THEREFORE NOT AVAILABLE FOR EVALUATION; HOWEVER, THE PATIENT¿S SYSTEM CONTROLLERS (SERIAL NUMBERS (B)(4)) WERE RETURNED FOR ANALYSIS. A SPECIFIC CORRELATION BETWEEN THE PATIENT¿S EXPIRATION AND THE DEVICE COULD NOT CONCLUSIVELY BE DETERMINED; HOWEVER, EVALUATION OF SYSTEM CONTROLLER (B)(4) REVEALED DAMAGE TO THE DRIVE CIRCUIT COMPONENTS WHICH SUGGEST A POSSIBLE ISSUE WITH THE PERCUTANEOUS LEAD. THE SYSTEM CONTROLLER SERIAL NUMBER (B)(4) WAS FUNCTIONALLY TESTED USING THE LABORATORY EQUIPMENT AND WAS FOUND TO FUNCTION AS INTENDED. THE DATA LOG FILE WAS SUCCESSFULLY RETRIEVED AND THE RECORDED INFORMATION INDICATED THAT THIS WAS THE PATIENT¿S BACKUP DEVICE. THE EVALUATION OF THE SYSTEM CONTROLLER SERIAL NUMBER (B)(4) REVEALED A DAMAGED/BURNED DRIVE CIRCUIT COMPONENT. AS A RESULT THE SYSTEM CONTROLLER WAS NOT ABLE TO OPERATE THE TEST PUMP DURING ANALYSIS. THE DATA LOG FILE RETRIEVED FROM THE RETURNED SYSTEM CONTROLLER CONTAINED 2 MINUTES OF EVENTS, RECORDED FROM TIME STAMP OF DAY 1907, 18 HOURS AND 43 MINUTES TO TIME STAMP OF DAY 1907 , 18 HOURS AND 45 MINUTES. THE DATA LOG FILE WAS FILLED WITH EVENTS WHERE THE SYSTEM CONTROLLER WAS UNSUCCESSFULLY ATTEMPTING TO OPERATE THE PUMP. THESE EVENTS WERE ACCOMPANIED BY LOW SPEED HAZARD AND LOW FLOW HAZARD ALARMS. THE RECORDED POWER RANGED BETWEEN 0-25 WATTS, THE FLOW ESTIMATION WAS 0 LPM AND THE PI WAS 6.4-12.1. ALTHOUGH A SPECIFIC CAUSE WAS UNABLE TO BE DETERMINED, BASED ON OUR EXPERIENCE, THE DAMAGE TO THE DRIVE CIRCUIT COMPONENTS MAY SUGGEST A POSSIBLE ISSUE WITH THE PERCUTANEOUS LEAD. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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 (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT¿S HUSBAND WAS DRIVING AND NOTICED THAT THE PATIENT WAS UNRESPONSIVE, AND WAS NOT BREATHING. THE PATIENT¿S HUSBAND TOOK THE PATIENT TO THE EMERGENCY ROOM, AND CPR WAS GIVEN AND SHOCKED BUT NO RESPONSE. THE LVAD CLINICIAN REPORTED THAT ALARMS WERE OBSERVED, BUT THEY WERE UNCERTAIN IF THE PUMP WAS ON AND WORKING. THEY COULD NOT RESUSCITATE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762689 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 104911

    Patients

    Seq Age Sex Outcome Treatment
    1 Death