BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP G5 DELIVERY SYSTEM

    MDR report key: 23661047 · Received November 26, 2025

    Report

    Report Number
    2135147-2025-06995
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 3, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NPS
    UDI-DI
    05415067050786
    PMA / PMN Number
    P230007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED OTHER COMPLAINTS REPORTED TO THIS LOT AND APPEAR TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. BASED ON AVAILABLE INFORMATION, THE INVESTIGATION DETERMINED THE REPORTED DIFFICULT TO FLUSH TO BE POTENTIALLY RELATED TO A PRODUCT QUALITY ISSUE. THIS COMPLAINT IS WITHIN THE SCOPE OF AN EXCEPTION AS THE COMPLAINT DESCRIPTION AND DEVICE CODE MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THEREFORE, THIS INCIDENT IS POINTING TO EXCEPTION (ISSUE) 136179 AND EXCEPTION (ACTION) 142561. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 4 TRICUSPID REGURGITATION (TR) FOR A TRICLIP PROCEDURE. DURING DEVICE PREPARATION, THERE WAS CHALLENGES DE-AIRING THE SYSTEM PER IFU INSTRUCTIONS. TROUBLESHOOTING WAS PREFORMED BY MOVING THE CDS FROM A HORIZONTAL POSITION TO A VERTICAL POSITION AND AIR WAS VISUALIZED RUNNING THROUGH THE CDS SLEEVE SHAFT. THEN THE CDS HANDLE WAS MOVED IN THE VERTICAL POSITION AND TRANSLATED A FEW TIMES BEFORE NO AIR WAS VISUALIZED. DURING THE PROCEDURE, BOTH TRICLIPS WERE SUCCESSFULLY IMPLANTED. THE FINAL TR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536514 TRICLIP G5 DELIVERY SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT VASCULAR INC. TCDS0802-XTW 50710R1108 05415067050786

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown