BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRICLIP G4 SYSTEM

    MDR report key: 20869537 · Received December 6, 2024

    Report

    Report Number
    2135147-2024-06215
    Event Type
    Injury
    Date Received
    December 6, 2024
    Date of Event
    November 14, 2024
    Report Date
    January 6, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NPS
    UDI-DI
    08717648334269
    PMA / PMN Number
    P230007
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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 IDENTIFIED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A LOT-SPECIFIC PRODUCT ISSUE. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED DEVICE DAMAGED BY ANOTHER DEVICE (DISLODGED) AND SLDA APPEAR TO BE RELATED TO PROCEDURAL CONDITIONS, AND DUE TO THE SECOND CLIP INTERACTING WITH THIS FIRST IMPLANTED CLIP, CAUSING SLDA OF THIS FIRST IMPLANTED CLIP. A CAUSE FOR ENTRAPMENT OF DEVICE (CLIP BECOMING CAUGHT IN ANATOMY), HOWEVER, COULD NOT BE DETERMINED. IMAGE RESOLUTION POOR IS RELATED TO PATIENT AND PROCEDURAL CONDITIONS AS IMAGING QUALITY THROUGHOUT THE WHOLE PROCEDURE WAS POOR DUE TO THE TAVI IMPLANT. UNEXPECTED MEDICAL INTERVENTIONS WERE A RESULT OF CASE-SPECIFIC CIRCUMSTANCES. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT PRESENTED WITH GRADE 2-3 FUNCTIONAL TRICUSPID REGURGITATION (TR), HISTORY OF TAVI (NON-ABBOTT), HISTORY OF NON-ABBOTT M-TEER ON (B)(6) 2024, AND SYMPTOMATIC WITH DYSPNEA FOR A TRICLIP PROCEDURE. IMAGING QUALITY THROUGHOUT THE WHOLE PROCEDURE WAS POOR DUE TO THE TAVI IMPLANT. THE FIRST CLIP STEERED INTO THE RIGHT ATRIUM (RA), THERE WAS LESS HEIGHT ABOVE THE VALVE, AND - KNOB WAS ADDED. ECHOCARDIOGRAM QUALITY WAS POOR WHEN THE CLIP WAS STEERED UNDER AND BETWEEN LEAFLETS MID A/S (ANTERIOR AND SEPTAL), AND WHEN IT WAS OPENED. THE CLIP BECAME STUCK AT THE SEPTAL LEAFLET AND THE ROOT-CAUSE COULD NOT BE DETERMINED. THE CLIP WAS ON THE SEPTAL LEAFLET, WHICH WAS IMMOBILE. AFTER A FEW CAREFUL ATTEMPTS, A SUCCESSFUL GRASP OF THE MID ANTERIOR LEAFLET WAS ACHIEVED, AND THERE WAS ALMOST NO REDUCTION IN TR DUE TO THE NON-IDEAL LOCATION OF CLIP. THERE WAS SUFFICIENT LEAFLET INSERTION, CHECKED ONLY IN TG-SAX VIEW (DUE TO IMAGING CHALLENGES IN OTHER VIEWS). THE REMAINING TR WAS AT A CENTRAL LOCATION (POSTERIOR TO THE FIRST CLIP). A SECOND CLIP WAS DECODE TO IMPLANT ON CENTRAL A/S. DURING MANIPULATION AND MOVEMENT, THE SECOND CLIP MADE CONTACT WITH THE FIRST CLIP. THE FIRST CLIP DETACHED FROM THE ANTERIOR LEAFLET,15 MINUTES AFTER SECOND CLIP PLACEMENT. THE TR INCREASED FROM MODERATE 1+/2 TO 2+ AGAIN. THE CLIP REMAINED STABLE ON THE SEPTAL LEAFLET. THE SECOND CLIP WAS IMPLANTED COMMISSURAL A/S AND THE THIRD CLIP WAS CENTRAL A/S. THE TR WAS REDUCED TO GRADE 2. THE PATIENT WAS STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2489931 TRICLIP G4 SYSTEM TRICUSPID VALVE REPAIR DEVICE, PERCUTANEOUSLY DELIVERED NPS ABBOTT MEDICAL 40424R1006 08717648334269

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention PREVIOUSLY IMPLANTED M-TEER DEVICE (PASCAL NON-ABB| PREVIOUSLY IMPLANTED TAVI (EVOLUT- NON-ABBOTT)| TRICLIP| TRICLIP STEERABLE GUIDE CATHETER