BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 19519450 · Received June 12, 2024

    Report

    Report Number
    2135147-2024-02730
    Event Type
    Malfunction
    Date Received
    June 12, 2024
    Date of Event
    May 20, 2024
    Report Date
    June 26, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037404
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    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

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED DETACHED GRIPPER LINE AND SINGLE GRIPPER ACTUATION ISSUE WERE CONFIRMED VIA RETURNED DEVICE 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 REPORTED FROM THIS LOT. BASED ON AVAILABLE INFORMATION AND THE RETURNED DEVICE ANALYSIS, THE REPORTED SINGLE GRIPPER ACTUATION ISSUE IS A CASCADING EVENT OF THE REPORTED DETACHED GRIPPER LINE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) GRADE 4+. A XTW (LOT: 30807A2012) WAS IMPLANTED FIRST SUCCESSFULLY, REDUCING MR TO GRADE 2+. A SECOND XT (LOT: 30920A1066) WAS ATTEMPTED TO BE IMPLANTED BUT THE POSTERIOR GRIPPER WAS NOT DROPPING DURING SIMULTANEOUS ACTUATION. THE ANTERIOR GRIPPER FUNCTIONED NORMALLY. TROUBLESHOOTING WAS PERFORMED BUT WAS UNSUCCESSFUL. THE CLIP WAS REMOVED AND THE GRIPPER LINE WAS OBSERVED TO BE DETACHED. A REPLACEMENT XT (LOT: 30920A1059) WAS IMPLANTED SUCCESSFULLY. THE PROCEDURE ENDED WITH MR REDUCED TO TRACE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    157127 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30920A1066 05415067037404

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Male STEERABLE GUIDE CATHETER.