BEUDAMED
    FDA Adverse Event Death Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7037116 · Received November 16, 2017

    Report

    Report Number
    3004582654-2017-00028
    Event Type
    Death
    Date Received
    November 16, 2017
    Date of Event
    October 23, 2017
    Report Date
    November 16, 2017
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    EXEMPTION NUMBER: E2013009. BERLIN HEART INC. (IMPORTER NUMBER: (B)(4)) IS SUBMITTING THE REPORT ON BEHALF OF BERLIN HEART GMBH (MANUFACTURER). THE VAD WAS IMPLANTED ON (B)(6) 2017. NO DEPOSITS WERE REPORTED INSIDE THE PUMP AT THE TIME OF THE INCIDENT. MOBILE CLOT WAS NOTICED INSIDE CANNULA AT THE TIME OF THE STROKE. THE DECISION WAS MADE TO WITHDRAW THE SUPPORT. THE PATIENT DIED ON (B)(6) 2017 AFTER 40 DAYS OF SUPPORT AFTER DEVICE SUPPORT WAS DISCONTINUED. G8 ADVERSE EVENT TERM(S): DEATH / HEMORRHAGIC STROKE.

    Description of Event or Problem · 0

    THE SITE CONTACTED BERLIN HEART CLINICAL AFFAIRS TO REPORT THAT, A PATIENT SUPPORTED BY AN EXCOR BLOOD PUMP IN THE LVAD CONFIGURATION, STARTED HAVING SEIZURES ON THE MORNING OF (B)(6) 2017. CT SHOWED 2 SMALL EMBOLIC STROKES. LATER THAT DAY, SHE WAS HAVING MORE SEIZURES WITH LABORED BREATHING. PATIENT WAS TAKEN BACK TO CT AND AN EMBOLIC EVENT THAT HAD CONVERTED TO A HEMORRHAGIC STROKE. ALL ANTICOAGULATION MEDICATION WAS STOPPED AT THIS POINT. ON TUESDAY, (B)(6) 2017, IT WAS NOTICE SHE WAS NOT BREATHING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816466 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Death