BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 1652838 · Received April 6, 2010

    Report

    Report Number
    2916596-2010-00072
    Event Type
    Death
    Date Received
    April 6, 2010
    Date of Event
    January 21, 2010
    Report Date
    March 10, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF THE DEVICE REVEALED THAT THERE WAS NO EVIDENCE OF THROMBUS OR DEPOSITION ON THE PROXIMAL AND DISTAL SIDES OF THE PUMP. EXAMINATION OF THE SMOOTH AND TEXTURED BLOOD-CONTACTING SURFACES WITHIN THE PUMP DID NOT REVEAL ANY ANOMALIES OR DEPOSITIONS THAT WOULD HAVE AFFECTED THE FUNCTIONALITY OF THE DEVICE. IN ADDITION, THE PUMP BEARINGS DID NOT REVEAL ANY DEPOSITION OR DETECTABLE WEAR THAT WOULD HAVE AFFECTED PUMP FUNCTION. EVALUATION AND CONTINUITY TESTING OF THE PERCUTANEOUS LEAD WAS UNREMARKABLE. THE PUMP WAS REASSEMBLED AND FUNCTIONALLY TESTED UNDER VARIOUS LOADED CONDITIONS USING A MOCK CIRCULATORY LOOP AND OPERATED AS INTENDED. A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THE DEVICE MET ALL APPLICABLE SPECIFICATIONS. THE RETURNED SYSTEM CONTROLLER WAS FOUND TO FUNCTION AS INTENDED DURING OUR ANALYSIS AND REVIEW OF THE LOG FILE DATA DID NOT REVEAL ANY RECORDED EVENTS THAT HAD ANY RELEVANCE TO THE REPORTED PATIENT DEATH. BASED ON OUR EVALUATION, IT DOES NOT APPEAR THAT THE RETURNED DEVICES CONTRIBUTED TO THE REPORTED EVENT AND NO CONCLUSION CAN BE MADE AS TO THE CAUSE OF THE EVENT. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THREE MONTHS PRIOR TO THE REPORTED EVENT, THE HOSPITAL HAD RETURNED THE EXPLANTED DEVICE AS A NON-COMPLAINT LVAD, ALONG WITH THE PATIENT'S SYSTEM CONTROLLER. THE RETURNED DEVICES WERE AWAITING DEVICE ANALYSIS PER THE MANUFACTURE'S PROCEDURE. THE HOSPITAL LATER REPORTED TO THE MANUFACTURER THAT THE DEVICES HAD BEEN RETURNED DUE TO AN UNEXPLAINED PATIENT DEATH. THE PATIENT'S CAUSE OF DEATH WAS NOT REPORTED TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 86685

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Death