BEUDAMED
    FDA Adverse Event Death Summary report: N

    ABBOTT

    MDR report key: 10038198 · Received April 29, 2020

    Report

    Report Number
    10038198
    Event Type
    Death
    Date Received
    April 29, 2020
    Date of Event
    December 24, 2019
    Report Date
    April 24, 2020
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    OKR
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A (B)(6) Y/O MALE WITH A HISTORY OF STAGE D HF WITH LV SYSTOLIC DYSFUNCTION 2/2 NICM (EOSINOPHILIC MYOCARDITIS) S/P HM3 LVAD AS DT AND TVR ((B)(6) 2019), WITH RECENT SAH NOW OFF ANTI-COAGULATION, WAS SENT TO THE ED FROM VAD. HE WAS ADMITTED TO CTICU WITH SUSPICION OF PUMP THROMBUS. UPON ARRIVAL TO THE CTICU HE REQUIRED INTUBATION AND MECHANICAL VENTILATION AND WAS QUICKLY ESCALATED TO MAX DOSE PRESSORS IN THE SETTING OF A PROFOUND LACTIC ACIDOSIS. HE ALSO HAD NEUROLOGICAL DECLINE. HIS CT SHOWED EVIDENCE OF THROMBUS AT THE AORTA-OUTFLOW GRAFT JUNCTION, WHICH LIKELY SHOWED MULTIPLE ORGANS. PER FAMILY WISHES CARE WAS WITHDRAWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    473941 ABBOTT HEARTMATE 3 OKR ABBOTT MEDICAL HM3

    Patients

    Seq Age Sex Outcome Treatment
    1 29 YR Death