BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRICLIP G4 DELIVERY SYSTEM (TCDS)

    MDR report key: 15397713 · Received September 10, 2022

    Report

    Report Number
    2135147-2022-01146
    Event Type
    Malfunction
    Date Received
    September 10, 2022
    Date of Event
    June 22, 2022
    Report Date
    September 10, 2022
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    NOT APPROVED
    Removal / Correction Number
    2024168-9/6/2022-003-C
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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 NO SIMILAR COMPLAINTS FROM THE LOT. ALL INFORMATION WAS INVESTIGATED AND BASED ON INFORMATION PROVIDED AND WITHOUT THE DEVICE TO ANALYZE, A CAUSE FOR THE REPORTED UNINTENDED MOVEMENT ASSOCIATED WITH CLIP OPENING WHILE ESTABLISHING FINAL ARM ANGLE (EFAA) COULD NOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE DEVICE IS INCLUDED IN THE CORRECTION NOTICE ISSUED BY ABBOTT ON 06 SEP 2022 FOR CLIPS NOT BEING ABLE TO ESTABLISH FINAL ARM ANGLE (EFAA) AND/OR CLIP OPENING WHILE LOCKED (COWL) WITH THE MITRACLIP AND TRICLIP DELIVERY SYSTEM(S).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS WAS A TRICLIP PROCEDURE TO TREAT MIXED TRICUSPID REGURGITATION (TR) WITH A GRADE OF 5. DURING ESTABLISHING FINAL ARM ANGLE (EFAA) WITH THE SECOND CLIP, THE CLIP OPENED PARTIALLY. THE LOCK LINE WAS ALREADY REMOVED. THE CLIP WAS LEFT AS IT WAS SINCE THERE WAS A REDUCTION OF THE JET. DURING EFAA OF THE FOURTH CLIP, THE CLIP STARTED TO OPEN. TROUBLESHOOTING WAS PERFORMED, BUT THE CLIP WAS STILL OPENING. THE CLIP WAS REMOVED AND EXCHANGED FOR ANOTHER CLIP. FOUR CLIPS WERE IMPLANTED, AND THE TR WAS REDUCED TO 3. AN ECHOCARDIOGRAM WAS PERFORMED AND A TEAR WAS SUSPECTED IN THE ANTERIOR LEAFLET, WHICH EXPLAINED THE REMAINING JET. NO ADDITIONAL INFORMATION WAS PROVIDED. AS OF AUG 22, 2022 THE DEVICE IS INCLUDED IN THE CORRECTION NOTICE DUE TO AN INCREASED RATE OF REPORTS FOR CLIPS NOT BEING ABLE TO ESTABLISH FINAL ARM ANGLE (EFAA) AND CLIP OPENING WHILE LOCKED (COWL) WITH THE MITRACLIP AND TRICLIP DELIVERY SYSTEM(S).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1139571 TRICLIP G4 DELIVERY SYSTEM (TCDS) TRICLIP NKM ABBOTT MEDICAL 20210R1026

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown STEERABLE GUIDE CATHETER