BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BERLIN HEART EXCOR PEDIATRIC VAD

    MDR report key: 7314569 · Received March 5, 2018

    Report

    Report Number
    3004582654-2018-00009
    Event Type
    Injury
    Date Received
    March 5, 2018
    Date of Event
    February 7, 2018
    Report Date
    March 5, 2018
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR
    Reporter Occupation
    OTHER

    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 SITE REPORTED THAT THE VAD PERFORMED APPROPRIATELY DURING THE EVENT AND THAT THE EVENT WAS RELATED TO THE COMPLEXITIES OF MEDICAL MANAGEMENT. THE PATIENT REMAINS ON SUPPORT. G8: ADVERSE EVENT TERM: ISCHEMIC CVA.

    Description of Event or Problem · 0

    BERLIN HEART WAS INFORMED BY THE CLINIC ON (B)(6) 2018 THAT A PATIENT IMPLANTED IN THE BIVAD CONFIGURATION HAD AN ISCHEMIC CVA ON (B)(6) 2018 FOLLOWING THE DISAPPEARANCE OF FIBRIN "DEPOSITS" OF THE LEFT PUMP, RESULTING IN FUNCTIONAL WEAKNESS IN BOTH ARMS DESPITE TREATMENT WITH CLOPIDOGREL AND CORTESTERIODS. DESPITE TREATMENT WITH CLOPIDOGREL, ASPIRIN, DIPRIDIAMOL AND LWMH, PATIENT CONTINUED TO DEVELOP FIBRIN DEPOSITS IN THE PUMPS. AN ADDITIONAL ISCHEMIC CVA OCCURRED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158277 BERLIN HEART EXCOR PEDIATRIC VAD VENTRICULAR ASSIST DEVICE DSQ BERLIN HEART GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Life Threatening