BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 21791749 · Received April 7, 2025

    Report

    Report Number
    2135147-2025-01824
    Event Type
    Malfunction
    Date Received
    April 7, 2025
    Date of Event
    March 13, 2025
    Report Date
    June 26, 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 SLEEVE TIP RING WAS CONFIRMED TO BE BROKEN. ADDITIONALLY, THE CLIP COVER WAS LIFTED, THE CLIP INTRODUCER WAS TORN, THE STEERABLE SLEEVE SHAFT WAS TORN, AND THE L-LOCK TABS WERE OBSERVED TO BE SCRATCHED. THE REPORTED UNINTENDED MOVEMENT, DIFFICULT TO REMOVE CDS FROM SGC, DIFFICULT POSITIONING IN ANATOMY, AND AUDIBLE NOISE 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 DIFFICULT TO REMOVE CDS FROM SGC, LIFTED CLIP COVER, TORN CLIP INTRODUCER, AND SCRATCHED L-LOCK TABS WERE LIKELY DUE TO PROCEDURAL CIRCUMSTANCES (TECHNIQUE OF CLIP REMOVAL, TROUBLESHOOTING TECHNIQUE). THE REPORTED AUDIBLE NOISE, UNINTENDED MOVEMENT, AND OBSERVED TORN STEERABLE SLEEVE SHAFT WERE RESULTS OF THE BROKEN TIP RING. THE REPORTED DIFFICULT POSITIONING IN ANATOMY WAS A RESULT OF THE REPORTED UNINTENDED MOVEMENT. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES. CODES REMOVED: H6 MEDICAL DEVICE PROBLEM CODE: 1212 ENTRAPMENT OF DEVICE. CODES ADDED: H6 MEDICAL DEVICE PROBLEM CODE: 1157 DIFFICULT OR DELAYED POSITIONING.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. 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 THAT A TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL TRICUSPID REGURGITATION (TR) WITH A GRADE OF 3 AND CHIARI NETWORK. A TRICLIP WAS INSERTED AND DEPLOYED ON THE TRICUSPID VALVE. A TRICLIP XTW WAS INSERTED. HOWEVER, WHILE FLEXING THE CLIP DELIVERY SYSTEM (CDS), A CRACK SOUND WAS HEARD AND THE CLIP LOST ITS FLEX. A DECISION WAS MADE TO REMOVE THE CLIP. HOWEVER, THE CLIP BECAME CAUGHT IN THE CHIARI NETWORK DUE TO THE UNCONTROLLED LOSING OF FLEX. TROUBLESHOOTING WAS PERFORMED, AND THE CLIP WAS ABLE TO BECOME FREE. HOWEVER, THE CLIP WAS UNABLE TO BE REMOVED THROUGH THE TRICLIP STEERABLE GUIDE CATHETER (TSGC). FORCE WAS REQUIRED TO REMOVE THE CLIP INTO THE SGC. FLUOROSCOPY WAS PERFORMED AND A STRUCTURE FROM THE CLIP WAS VISIBLE STILL WITHIN THE GUIDE. THEREFORE, THE TSGC AND THE CLIP WERE REMOVED FROM THE PATIENT TO ENSURE THAT THERE WAS NO FREE MATERIAL INSIDE THE PATIENT. A NEW SGC WAS INSERTED AND THE PROCEDURE WAS CONTINUED. TWO TRICLIPS WERE THEN INSERTED AND DEPLOYED ON THE TRICUSPID VALVE, REDUCING TR TO A GRADE OF 1. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1048253 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL TCDS0307-XTW 41118R1097 05415067045560

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other 1 IMPLANTED TRICLIP| TRICLIP STEERABLE GUIDE CATHETER