BEUDAMED
    FDA Adverse Event Death Summary report: N

    TRICLIP

    MDR report key: 23850804 · Received December 19, 2025

    Report

    Report Number
    23850804
    Event Type
    Death
    Date Received
    December 19, 2025
    Date of Event
    November 20, 2025
    Report Date
    December 18, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    NY
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    AFTER ADDED FLEX, IT WAS APPARENT THAT THE DEVICE WAS ALREADY UNDERNEATH THE TRICUSPID VALVE IN THE ANTEROSEPTAL COMMISSURE. AT THIS POINT, WE HAD NOT ADVANCED THE CLIP DELIVERY SYSTEM AT ALL. IT BECAME CLEAR THAT THEY WOULD NOT HAVE BEEN ENOUGH HEIGHT ABOVE THE TRICUSPID VALVE FOR US TO SUCCESSFULLY PERFORM THE PROCEDURE. WE TRIED TO RETRIEVE THE SYSTEM. THE SYSTEM APPEARED TO BE CAUGHT UNDERNEATH THE TRICUSPID VALVE APPARATUS. WITH SOME RETRACTION OF THE GUIDE CATHETER, WE WERE ABLE TO RETRIEVE THE DEVICE INTO THE RIGHT ATRIUM. WE THEN TRIED TO RE-SHEATH THE TRICUSPID CLIP DEVICE INTO THE GUIDE CATHETER AND PULLED THE SYSTEM INTO THE IVC [INFERIOR VENA CAVA]. AS SOON AS WE RETRACTED THE DEVICE INTO THE IVC, THERE WAS A NEW LARGE PERICARDIAL EFFUSION RESULTING IN PERICARDIAL TAMPONADE. THE PATIENT HAD HEMODYNAMIC COMPROMISE AT THAT POINT. WE PERFORMED EMERGENT PERICARDIOCENTESIS. THERE CONTINUE TO BE ONGOING EXTRAVASATION OF BLOOD, AND SHE CONTINUED TO BECOME HEMODYNAMICALLY UNSTABLE. WE CALLED CARDIAC SURGERY FOR CONSULTATION. DOCTOR MADE THE DECISION TO OPEN THE PATIENT TO TRY IDENTIFYING AND REPAIR THE INJURY. WITH ONGOING CPR, EMERGENT STERNOTOMY WAS PERFORMED. CARDIAC EXPLORATION SHOWED THE LOCATION OF TEAR TO BE IN THE IVC. THE TRI CLIP GUIDE CATHETER WAS REMOVED, AND THE DEVICE WAS EXCHANGED WITH A 22 FRENCH DRY SEAL. A 20 FRENCH SHEATH WAS INSERTED IN THE LEFT FEMORAL VEIN. UNFORTUNATELY, THE PATIENT CONTINUED TO BLEED AND WAS INTRAVASCULARLY VOLUME DEPLETED. MASSIVE TRANSFUSION PROTOCOL WAS GIVEN VIA BIFEMORAL SHEATHS. CONTINUOUS CARDIAC MASSAGE WAS PERFORMED WHILE DOCTOR WAS TRYING TO REPAIR THE IVC INJURY. A TOTAL OF 45 MINUTES OF ATTEMPT TO RESUSCITATE AND CONTROL THE BLEEDING WERE PERFORMED. HOWEVER, THE PATIENT NEVER REGAINED A PULSE AND WAS ULTIMATELY PRONOUNCED DEAD AT APPROXIMATELY 2 PM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    257934 TRICLIP TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL TRICLIP G4 XTW 50820R1083

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Death