BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 22786576 · Received August 12, 2025

    Report

    Report Number
    3004582654-2025-00045
    Event Type
    Death
    Date Received
    August 12, 2025
    Date of Event
    April 5, 2025
    Report Date
    August 12, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040492
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE PATIENT WAS IMPLANTED WITH A TOTAL OF FOUR CANNULAE ON (B)(6) 2025 AS FOLLOWS: THE LVAD EXCOR APEX CANNULA FOR CHILDREN Ø 12/9 MM (C22A-004); L 27 CM; LOT NO. 00145787. THE LVAD ARTERIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM (C80G-021M); LOT NO. 00125255. THE RVAD ATRIAL CANNULA Ø 12/9 MM; L 32 CM; HEAD 23 MM (C23V-004M); LOT NO. 00145788. THE RVAD ARTERIAL CANNULA FOR SMALL CHILDREN Ø 6 MM; L 25 CM (C80G-021M); LOT NO. 00148388. THE CANNULAE WERE IN USE ON THE PATIENT FROM ON (B)(6) 2025 UNTIL THEY WERE REMOVED FROM THE PATIENT ON (B)(6) 2025. THE EVENT OCCURRED ON 2025-04-05, WHICH IS (87 DAYS) AFTER THE CANNULAE WERE PLACED ON THE PATIENT. THE DETAILS OF THE LVAD APEX CANNULA LOT NO. 00145787 ARE PROVIDED IN SECTION D4. THE INFORMATION OF THE OTHER THREE CANNULAE USED ON THE PATIENT ARE AS FOLLOWS: THE CANNULA C23V-004M WITH LOT NO. 00145788: THE MANUFACTURE DATE FOR THIS LOT: 2024-08-29, THE EXPIRATION DATE FOR THIS LOT: 2027-07-25, UDI: (B)(4). THE CANNULA C80G-021M WITH LOT NO. 00125255: THE MANUFACTURE DATE FOR THIS LOT: 2022-11-03, THE EXPIRATION DATE FOR THIS LOT: 2025-09-30, UDI: (B)(4). THE CANNULA C80G-021M WITH LOT NO. 00148388: THE MANUFACTURE DATE FOR THIS LOT: 2024-10-25, THE EXPIRATION DATE FOR THIS LOT: 2027-10-02, UDI: (B)(4). WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR CANNULAE AND THE CANNULAE WERE PRODUCED ACCORDING TO OUR SPECIFICATIONS.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ON 2025-07-17 THAT A PATIENT SUFFERED AN HEMORRHAGIC STROKE AFTER RECEIVING FIBRINOLYTICS FOR A CLOT IN ONE OF THE CANNULAE. AS A RESULT, THE PATIENT WAS DECLARED BRAIN DEAD. CARE WAS WITHDRAWN FROM THE PATIENT ON (B)(6) 2025. THE PATIENT WAS BEING SUPPORTED WITH THE EXCOR SYSTEM IN BI-VAD CONFIGURATION. DEPOSITS WERE NOTED IN THE EXCOR CANNULAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1379406 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH C22A-004 00145787 04260090040492

    Patients

    Seq Age Sex Outcome Treatment
    1 24 MO Male Death