BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 23381258 · Received October 24, 2025

    Report

    Report Number
    2135147-2025-06096
    Event Type
    Death
    Date Received
    October 24, 2025
    Date of Event
    September 27, 2025
    Report Date
    November 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    UDI-DI
    05415067045560
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, A CAUSE FOR THE REPORTED HYPOTENSION AND DEATH CANNOT BE DETERMINED. DEATH AND HYPOTENSION ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH TRICLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 0

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 4, ON A PATIENT WITH ATRIAL FIBRILLATION (AF) AND PRESERVED RIGHT FUNCTION. A TRICLIP XTW AND A TRICLIP XT WERE INSERTED AND DEPLOYED ON THE ANTERIOR AND SEPTAL LEAFLETS, AND A TRICLIP XTW WAS INSERTED AND DEPLOYED ON THE POSTERIOR AND SEPTAL LEAFLET, BY PERFORMING A CLOVER STRATEGY, REDUCING TR TO A GRADE OF 1.5. THE CLIPS WERE NOTED TO BE STABLE ON THE LEAFLETS. HOWEVER, IT WAS NOTED THAT DURING THE PROCEDURE, THE PATIENT¿S BLOOD PRESSURE DROPPED. POST PROCEDURE, ONCE THE INTERVENTION WAS FINISHED, THE PATIENT WAS UNSTABLE, WITH LOW BLOOD PRESSURE. IT WAS NOTED THAT THIS WAS POTENTIALLY DUE TO A FAILURE OF THE RIGHT VENTRICLE FUNCTION. THE PATIENT DIED. IN THE PHYSICIAN¿S OPINION, THE CAUSE OF DEATH WAS POTENTIALLY DUE TO A RIGHT FAILURE, BUT THE PHYSICIAN WAS NOT CERTAIN. IT WAS NOTED THAT BECAUSE THE PROCEDURE WENT WELL, AND BECAUSE THE PATIENT LEFT THE CATH LAB WITH SOME LOW PRESSURE, THE PHYSICIAN DID NOT UNDERSTAND THE EXACT REASON FOR THE PATIENT DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2027781 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL TCDS0307-XTW 50506R2056 05415067045560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death