BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE LVAS

    MDR report key: 10108537 · Received June 2, 2020

    Report

    Report Number
    10108537
    Event Type
    Injury
    Date Received
    June 2, 2020
    Date of Event
    April 24, 2020
    Report Date
    May 21, 2020
    Manufacturer
    HEARTWARE INC.
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    HEARTWARE LEFT VENTRICULAR ASSIST DEVICE (LVAD) PATIENT WITH PRIOR HISTORY OF THROMBOSIS REQUIRING HEARTWARE TO HEARTWARE EXCHANGE, AND WHO HAD HEMOLYSIS ON THE 2ND LVAD ~ 6 MONTHS PRIOR TO THIS EVENT. LVAD EXCHANGE OF THE 2ND LVAD COULD NOT BE PURSUED AT THAT TIME DUE TO CONCOMITANT COMORBIDITIES OF BACTEREMIA AND INTRACRANIAL HEMORRHAGE; RESOLUTION OF HEMOLYSIS (PER LABS AND WAVEFORMS) ALLOWED FOR DISCHARGE OPPORTUNITY WITH PLANS FOR ELECTIVE LVAD EXCHANGE DURING A LATER TIME OF REDUCED BRAIN BLEED RISK. PATIENT ELECTED TO REPEATEDLY POSTPONE SURGERY DATES DESPITE CONVERSATIONS RE-RISK FOR RECURRENT HEMOLYSIS/STROKE. PATIENT PRESENTED TO HOSPITAL WHEN HIGH WATT ALARM AND HEMOGLOBINURIA RECURRED IN THE SETTING OF INTERNATIONAL NORMALIZED RATIO (INR) 2.0, AND ON ASPIRIN 81 MG (LOWER DOSE DUE TO RECENT ANEMIA/GASTROINTESTINAL BLEEDING). A SURGICAL ATTEMPT TO EXCHANGE HEARTWARE TO HEARTMATE 3 COULD NOT BE PURSUED DUE TO INABILITY TO VISUALIZE THE AORTA DUE TO SEVERE ADHESIONS, SO ANOTHER HEARTWARE TO HEARTWARE EXCHANGE WAS REQUIRED. SURGICAL FINDINGS INCLUDED TWISTING OF THE OUTFLOW GRAFT JUST AS IT CAME OFF THE HEARTWARE DEVICE COUPLING OF THE OUTFLOW GRAFT BEND RELIEF. AT THE TIME OF THIS REPORT PATIENT REMAINS TRACHED AND HOSPITALIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    576571 HEARTWARE LVAS VENTRICULAR (ASSIST) BYPASS DSQ HEARTWARE INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 28105 DA Hospitalization| L| R