BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3788272 · Received April 29, 2014

    Report

    Report Number
    2916596-2014-00566
    Event Type
    Death
    Date Received
    April 29, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 2, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SPECIFIC CAUSE FOR THE REPORTED CEREBRAL HEMORRHAGE AND A CORRELATION TO THE DEVICE COULD NOT BE DETERMINED. THE PUMP WAS NOT EXPLANTED; THEREFORE, A FULL EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS THAT WOULD AFFECT DEVICE FUNCTION OR PERFORMANCE. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 16 MONTHS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT WAS HOSPITALIZED FOR A CEREBRAL HEMORRHAGE AND THE PATIENT HAD LOST CONSCIOUSNESS. IT WAS ALSO REPORTED THAT THE PATIENT'S FAMILY INDICATED THAT THE PATIENT'S INR PRIOR TO THE EVENT WAS 6. THE PATIENT WAS INTUBATED AND TAKEN TO THE ICU. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT EXPIRED ON (B)(6) 2014 AND THE REPORTED CAUSE OF DEATH WAS CEREBRAL HEMORRHAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    255709 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104912 117831

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death