BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 21551551 · Received March 7, 2025

    Report

    Report Number
    2135147-2025-01179
    Event Type
    Malfunction
    Date Received
    March 7, 2025
    Date of Event
    February 17, 2025
    Report Date
    April 3, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    UDI-DI
    05415067045560
    PMA / PMN Number
    P230007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED GRIPPER ACTUATION ISSUE WAS CONFIRMED VIA DEVICE ANALYSIS. ADDITIONALLY, BOTH GRIPPER LINES WERE OBSERVED TO BE SEPARATED FROM THE L-LOCK SHAFT AND THE FRICTIONAL ELEMENT OBSERVED TO BE DEFORMED (BENT). THE REPORTED DIFFICULT OR DELAYED POSITIONING ANATOMY AND DIFFICULT IMAGING COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. 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 NO SIMILAR COMPLAINTS REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE REPORTED GRIPPER ACTUATION ISSUES ARE A CASCADING EVENT OF THE REPORTED DETACHED GRIPPER LINE. THE REPORTED DIFFICULT POSITIONING IN ANATOMY ASSOCIATED WITH CLIP BEING CAUGHT IN CHORDAE WAS DUE TO PROCEDURAL CIRCUMSTANCES. THE CAUSE OF THE REPORTED DIFFICULT IMAGING WAS UNABLE TO BE DETERMINED. THE OBSERVED BENT FRICTIONAL ELEMENTS ARE LIKELY A RESULT OF THE REPORTED CLIP BEING CAUGHT IN CHORDAE. THE INVESTIGATION DETERMINED THE DETACHED GRIPPER LINE TO BE RELATED TO A POTENTIAL 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, EXCEPTION (ISSUE) 130421 AND EXCEPTION (ACTION) 135842 ARE REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP IDENTIFIED THE LIKELY ROOT CAUSE TO BE MANUFACTURING VARIABILITY AT THE SUPPLIER. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THIS WAS A TRICLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5, A THIN SEPTAL LEAFLET AND AN ENLARGED ATRIUM. IT WAS NOTED THAT IMAGING WAS DIFFICULT. TWO CLIPS WERE SUCCESSFULLY IMPLANTED. TO FURTHER REDUCE TR, AN ADDITIONAL XTW CLIP WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED, BUT BECAME CAUGHT IN CHORDAE. THE CLIP WAS ABLE TO BE FREED FROM THE CHORDAE WITHOUT CAUSING DAMAGE. AFTER RETRACTING THE CLIP BACK INTO THE ATRIUM, IT WAS OBSERVED THAT BOTH GRIPPERS WERE NOT FUNCTIONING AS INTENDED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS REMOVED AND THE PROCEDURE WAS DISCONTINUED. TR WAS REDUCED TO A GRADE OF 4. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1281490 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL TCDS0307-XTW 40917R1068 05415067045560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown IMPLANTED TRICLIP (X2)| TRICLIP STEERABLE GUIDE CATHETER.