BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6004605 · Received October 6, 2016

    Report

    Report Number
    2916596-2016-01948
    Event Type
    Death
    Date Received
    October 6, 2016
    Date of Event
    August 29, 2016
    Report Date
    September 9, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE: 9 MONTHS. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED ELEVATED LACTATE DEHYDROGENASE LEVEL COULD NOT BE CONCLUSIVELY DETERMINED. HEMOLYSIS IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. 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). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016. THE CAUSE OF EXPIRATION WAS REPORTED AS FAILURE TO THRIVE. THE PATIENT HAD NOT BEEN GETTING ANY BETTER AND DECIDED TO DO HOME HOSPICE. THIS WAS THE PATIENT'S SECOND LVAD AND WAS SHOWING SIGNS OF CLOTTING OFF AGAIN. THE PUMP WILL NOT BE RETURNING FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED BUT HAS NOT BEEN PROVIDED.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT WAS REPORTED THAT THE PATIENT'S LACTATE DEHYDROGENASE (LDH) LEVEL HAD INCREASED, CAUSING CONCERN FOR PUMP THROMBOSIS; HOWEVER, A RAMP STUDY AND ECHOCARDIOGRAM WAS PERFORMED AND NO ISSUE WAS OBSERVED. IT WAS BELIEVED THAT THE PATIENT'S LDH LEVEL HAD INCREASED BECAUSE THE PATIENT HAD A LARGE AMOUNT OF KIDNEY STONES THAT COULD NOT BE REMOVED AND WAS CAUSING AN INFECTION. THE DOCTOR BELIEVED THAT THE PATIENT WAS AT RISK OF THROMBUS, BUT THROMBUS WAS NEVER OBSERVED. THE DEATH WAS REPORTEDLY NOT DEVICE-RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    659164 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death