BEUDAMED
    FDA Adverse Event Death Summary report: N

    EXCOR®

    MDR report key: 22569463 · Received July 22, 2025

    Report

    Report Number
    3004582654-2025-00040
    Event Type
    Death
    Date Received
    July 22, 2025
    Date of Event
    June 20, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040157
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE LVAD EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2025 UNTIL IT WAS REMOVED FROM THE PATIENT ON (B)(6) 2025. THE EVENT OCCURRED ON (B)(6) 2025, WHICH IS (31 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP AND THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE POLAND DISTRIBUTOR ON 2025-06-26 THAT A PATIENT SUFFERED A MINOR HEMORRHAGIC STROKE ON (B)(6) 2025, FOLLOWED BY A MASSIVE HEMORRHAGIC STROKE ON (B)(6) 2025, WHICH UNFORTUNATELY RESULTED IN DEATH. THE PATIENT WAS BEING SUPPORTED WITH AN EXCOR BLOOD PUMP PU VALVES; 15 ML IN/OUT; Ø 9 MM. ACCORDING TO THE SITE, THE EXCOR BLOOD PUMP MAINTAINED COMPLETE FILLING AND EJECTION AND NO DEPOSITS IN THE EXCOR BLOOD PUMP OR ANTICOAGULATION PROBLEM WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1785601 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P15P-001 04260090040157

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Female Death