BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRANSSEPTAL NEEDLE, BRK SERIES

    MDR report key: 23388095 · Received October 26, 2025

    Report

    Report Number
    3008452825-2025-00498
    Event Type
    Death
    Date Received
    October 26, 2025
    Date of Event
    September 10, 2025
    Report Date
    November 14, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    DRC
    UDI-DI
    05414734205122
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MODEL/LOT NUMBER INFORMATION WAS NOT ABLE TO BE OBTAINED FOR THIS DEVICE. THEREFORE, FULL UDI INFORMATION(D4) AND 510K(G3) ARE NOT AVAILABLE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: D9, G3, H2, H3, H6. THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE SINCE THE DEVICE WAS NOT RETURNED FOR ANALYSIS. REVIEW OF THE DEVICE HISTORY RECORD WAS NOT POSSIBLE AS THE LOT NUMBER IS UNKNOWN. BASED ON THE INFORMATION RECEIVED, THE CAUSE OF THE REPORTED INCIDENT COULD NOT BE CONCLUSIVELY DETERMINED. PER THE IFU, CARDIAC TAMPONADE AND PERICARDIAL EFFUSION ARE KNOWN RISKS DURING THE USE OF THIS DEVICE.

    Description of Event or Problem · 0

    DURING A MITRACLIP PROCEDURE, THE PATIENT DEVELOPED A PERICARDIAL EFFUSION AND EXPIRED. THE PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4+. A TRICLIP STEERABLE GUIDE CATHETER (TSGC) WAS USED OFF-LABEL WITH THE MITRACLIP CLIP DELIVERY SYSTEM (CDS) AS IT WAS ALSO PLANNED TO TREAT TRICUSPID REGURGITATION (TR) GRADE 3-4 AFTER THE MR. PATIENT WAS FRAIL BUT STABLE. INITIAL STEERING TO THE MITRAL VALVE WAS DIFFICULT DUE TO PROMINENT COUMADIN RIDGE. DURING INITIAL STEERING TO THE MITRAL VALVE A DROP OF BLOOD PRESSURE WAS NOTICED AND ECHOCARDIOGRAPHER CONFIRMED CIRCUMFERENTIAL PERICARDIAL EFFUSION. LOCATION WAS UNKNOWN AS BLEEDING SPREAD QUICKLY. PHYSICIAN CONCLUDED CARDIAC TAMPONADE WAS PRESENT. PROTAMINE ADMINISTERED. PATIENT TURNED HEMODYNAMICALLY UNSTABLE. PERICARDIOCENTESIS WAS PERFORMED AS THE TSGC AND CDS WERE REMOVED. PERICARDIOCENTESIS WAS UNSUCCESSFUL AND THE PATIENT'S CONDITION WORSENED. DUE TO THIS, OPEN HEART SURGERY WAS PERFORMED. AFTER INITIAL IMPROVEMENT WITH ECMO, THE PATIENT'S CONDITION DIMINISHED AND COULD NOT BE STABILIZED. AFTER SEVERAL UNSUCCESSFUL ATTEMPTS TO RESUSCITATE THE PATIENT DIED. IT WAS THOUGHT THE PERICARDIAL EFFUSION WAS DUE TO TRANSSEPTAL PUNCTURE AND WAS UNRELATED TO THE MITRACLIP SYSTEM. THERE WERE DIFFICULTIES WITH THE TRANSSEPTAL PUNCTURE DUE TO CHALLENGING ANATOMY AND POOR VISUALIZATION ON ECHO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2741374 TRANSSEPTAL NEEDLE, BRK SERIES TROCAR DRC ABBOTT MEDICAL 05414734205122

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| D