BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRICULAR (ASSIST) BYPASS

    MDR report key: 11332277 · Received February 16, 2021

    Report

    Report Number
    11332277
    Event Type
    Malfunction
    Date Received
    February 16, 2021
    Date of Event
    September 28, 2020
    Report Date
    January 14, 2021
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    HISTORY OF NONISCHEMIC CARDIOMYOPATHY (NICM) S/P LEFT VENTRICULAR ASSIST DEVICE (LVAD) NOW POD#0 S/P OHTX AND LVAD EXPLANT COMPLICATED BY COAGULOPATHY REQUIRING OPEN CHEST AND POST-OPERATIVE RV DYSFUNCTION (TOTAL ISCHEMIC TIME 240 MINUTES) AND VASOPLEGIC SHOCK (PRE-OP ENTRESTO AND AMIODARONE). HE IS BEING SEEN FOR CARDIOGENIC/VASOPLEGIC SHOCK, ACUTE SYSTOLIC RIGHT HEART FAILURE, METABOLIC LACTIC ACIDOSIS, AKI, COAGULOPATHY, AND ACUTE BLOOD LOSS ANEMIA. THESE CONDITIONS CARRY A HIGH RISK OF CAUSING IMMINENT AND/OR LIFE-THREATENING DETERIORATION IN THE PATIENT'S CONDITION AND REQUIRE MY PERSONAL MANAGEMENT IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    231798 VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORP

    Patients

    Seq Age Sex Outcome Treatment
    1 11315 DA