BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD)

    MDR report key: 18255168 · Received December 4, 2023

    Report

    Report Number
    2135147-2023-05303
    Event Type
    Malfunction
    Date Received
    December 4, 2023
    Date of Event
    November 10, 2023
    Report Date
    January 8, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 SINGLE GRIPPER ACTUATION (DIFFICULT TO OPEN OR CLOSE) AND GRIPPER LINE BREAK OF THE NON-TACTILE MARKER WERE CONFIRMED VIA RETURNED DEVICE ANALYSIS. ADDITIONALLY, THE TACTILE MARKER GRIPPER LINE WAS OBSERVED TO BE BENT. 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. BASED ON AVAILABLE INFORMATION, THE REPORTED SINGLE GRIPPER ACTUATION ISSUE WAS A CASCADING EVENT OF THE REPORTED BROKEN GRIPPER LINE. THE INVESTIGATION DETERMINED THE BROKEN NON-TACTILE MARKER GRIPPER LINE AND BENT TACTILE MARKER GRIPPER LINE MAY BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE, THEREFORE, EXCEPTION (ISSUE) 128065 AND EXCEPTION (ACTION) 133005 ARE REFERENCED. PER 90873418, REVISION F, THIS COMPLAINT IS WITHIN THE SCOPE OF EXCEPTION (ISSUE) 128065 AND EXCEPTION (ACTION) 133005 AS THE COMPLAINT DESCRIPTION AND DEVICE CODES MATCH THE SPECIFIC ISSUE DESCRIBED IN THE EXCEPTION. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP FOUND THE INVESTIGATION TO BE INCONCLUSIVE AND DID NOT CONFIRM IT TO BE RELATED TO THE MANUFACTURE, DESIGN OR LABELING OF THE PRODUCT, HOWEVER, A POTENTIAL CONTRIBUTING FACTOR THOUGH NOT CONFIRMED WAS DETERMINED TO BE METHOD, DUE TO THE GRIPPER LINE BEING INADVERTENTLY SNAGGED ON THE LOADING HOOK, LEADING TO KINKS. THE CORRECTIVE ACTION ASSOCIATED WITH PROCEDURE IMPROVEMENTS 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) 2023, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) GRADE 4. WHEN THE NTW MITRACLIP WAS INSIDE THE PATIENT ANATOMY, ONE OF THE GRIPPER LINES BROKE DURING INDEPENDENT GRIPPER CAPTURE. THE GRIPPERS HAD BEEN CYCLED APPROXIMATELY FIVE TIMES. THE DEVICE WAS REMOVED AS A SINGLE UNIT AND A REPLACEMENT XTW MITRACLIP WAS IMPLANTED WITHOUT ISSUE. THERE WERE NO PATIENT CONSEQUENCES OR CLINICALLY SIGNIFICANT DELAY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1503369 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDD) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 30217R1064

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown