BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3945610 · Received July 7, 2014

    Report

    Report Number
    2916596-2014-01130
    Event Type
    Death
    Date Received
    July 7, 2014
    Date of Event
    May 6, 2014
    Report Date
    June 6, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    MEDICAL ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION. THE PUMP AND ALL ASSOCIATED EQUIPMENT WERE NOT RETURNED. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF SUSPECTED THROMBUS COULD NOT BE CONCLUSIVELY DETERMINED. THE INSTRUCTIONS FOR USE LISTS THROMBOSIS, HEMOLYSIS AND BLEEDING AS POSSIBLE ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED THAT 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). IT WAS REPORTED BY THE VAD DEPARTMENT'S MEDICAL ASSISTANT THAT THE PATIENT HAD BEEN DISCHARGED TO HOSPICE AND EXPIRED THERE ON (B)(6) 2014 DUE TO THROMBUS IN THE PUMP.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION. IT WAS REPORTED THAT THE PATIENT HAD INCREASED LACTATE DEHYDROGENASE (LDH) LEVELS FROM 185 TO 1000, INCREASED POWER AND DECREASED PI EVENTS. A HEPARIN INFUSION WAS STARTED AND ASPIRIN (ASA) RESTARTED ON (B)(6), 2014 AND THE PUMP SPEED WAS DECREASED. THE PATIENT HAD A COLONOSCOPY DUE TO GI BLEEDING AND HAD BEEN TAKEN OFF ALL ANTICOAGULATION MEDICATION. THE COLONOSCOPY REVEALED A LARGE ULCER ON THE RIGHT COLON WITH ISCHEMIA NOTED. THE PATIENT¿S REGIMEN PRIOR TO THE REPORTED EVENT WAS ASA, COUMADIN, AND PERSANTINE. NO LOG FILES ARE AVAILABLE AND THE PUMP WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    393215 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122810

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death