BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP G4, XT-W

    MDR report key: 23672022 · Received November 28, 2025

    Report

    Report Number
    MW5179484
    Event Type
    Death
    Date Received
    November 28, 2025
    Date of Event
    November 20, 2025
    Report Date
    November 26, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DEATH OCCURRED DURING AN ELECTIVE TRICUSPID TRANSCATHETER EDGE TO EDGE REPAIR USING A TRICLIP G4, XT-W DEVICE, DUE TO AN INTRAOPERATIVE TEAR OF HEART AND VENA CAVA. THE DEVICE WAS REPORTEDLY ADVANCED INTO THE RIGHT ATRIUM AND DIRECTED TOWARD THE TRICUSPID VALVE, AT WHICH TIME IT BECAME "CAUGHT UNDERNEATH" THE TRICUSPID VALVE APPARATUS AND THUS WAS NOT EXTENDED OPEN. INSTEAD, THE DEVICE WAS REPORTEDLY RETRACTED INTO THE RIGHT ATRIUM AND RE-SHEATHED. IT IS REPORTED THAT AS SOON AS THE DEVICE WAS PULLED INTO THE INFERIOR VENA CAVA, A LARGE PERICARDIAL EFFUSION WITH TAMPONADE DEVELOPED. AUTOPSY REVEALED MYOCARDIAL ABRASIONS AND A TORN CHORDA TENDINEA WHERE THE DEVICE BECAME TANGLED IN THE TRICUSPID VALVE AND A LARGE TEAR OF THE RIGHT ATRIAL WALL EXTENDING INTO THE INFERIOR VENA CAVA. THE TRICLIP WAS DISCARDED BY THE HOSPITAL WITHOUT EXAMINATION. CLINICAL DIAGNOSIS OF SEVERE TRICUSPID REGURGITATION. AUTOPSY FINDING OF FOCAL THICKENING OF ANTERIOR TRICUSPID LEAFLET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2400081 TRICLIP G4, XT-W TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Death