BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCOR®

    MDR report key: 22978530 · Received September 5, 2025

    Report

    Report Number
    3004582654-2025-00046
    Event Type
    Injury
    Date Received
    September 5, 2025
    Date of Event
    August 11, 2025
    Report Date
    September 5, 2025
    Manufacturer
    BERLIN HEART GMBH
    Product Code
    DSQ
    UDI-DI
    04260090040027
    PMA / PMN Number
    P160035
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE RVAD EXCOR BLOOD PUMP PU VALVES; 60 ML IN/OUT; Ø 12 MM; SN (B)(6) WAS IN USE ON THE PATIENT FROM (B)(6) 2025 TO DATE. THE LVAD EXCOR BLOOD PUMP USED ON THIS PATIENT IS AN 80 ML IN/OUT Ø 12 MM PUMP WHICH IS NOT DISTRIBUTED IN THE US MARKET. THEREFORE, A REPORT FOR LVAD IS NOT REQUIRED TO BE SUBMITTED. THE EVENT OCCURRED ON 2025-08-11, WHICH IS (10 DAYS) AFTER THE PUMP WAS PLACED ON THE PATIENT. WE HAVE REVIEWED THE PRODUCTION RECORDS OF THE EXCOR BLOOD PUMP AND CONCLUDED THAT THE PUMP WAS PRODUCED ACCORDING TO OUR SPECIFICATION.

    Description of Event or Problem · 0

    BERLIN HEART GMBH CLINICAL AFFAIRS WAS INFORMED BY THE CLINIC ON (B)(6) 2025 THAT THE PATIENT ON BVAD, HAD SUFFERED AN ISCHEMIC STROKE SHORTLY AFTER RE-OPERATION BECAUSE OF RETROSTERNAL COLLECTION. VERY LITTLE FIBRIN SPOTS WERE SEEN IN BOTH EXCOR BLOOD PUMPS. THE PATIENT WAS ON ECMO SUPPORT FOR SEVERAL DAYS PRIOR TO THE IMPLANT OF THE BERLIN HEART EXCOR SYSTEM. THE BLOOD PUMPS PERFORMED AS INTENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306558 EXCOR® VENTRICULAR (ASSIST) BYPASS DSQ BERLIN HEART GMBH P60P-001 04260090040027

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Other