BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR)

    MDR report key: 20441393 · Received October 14, 2024

    Report

    Report Number
    2135147-2024-05070
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 23, 2024
    Report Date
    November 1, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037381
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED SINGLE GRIPPER ACTUATION ISSUE WAS CONFIRMED DUE TO A SEPARATED GRIPPER LINE. THE REPORTED DIFFICULT OR DELAYED POSITIONING 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 DID NOT INDICATE A LOT-SPECIFIC QUALITY ISSUE. BASED ON AVAILABLE INFORMATION THE REPORTED DIFFICULT OR DELAYED POSITIONING APPEARS TO BE RELATED TO PROCEDURAL CONDITIONS. THE REPORTED SINGLE GRIPPER ACTUATION ISSUE DUE TO THE SEPARATED GRIPPER LINE WAS DETERMINED TO BE 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, AN EXCEPTION (ISSUE) 130421 IS REFERENCED. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE PROBABLE ROOT CAUSE TO BE MANUFACTURING VARIABILITY OF THE L-LOCK COMPONENT, LEADING TO HIGHER CLEARANCE THAN NOMINAL AND CAN INCREASE THE LIKELIHOOD OF A GRIPPER LINE SLIP DURING THE PROCEDURE. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS BEEN RECEIVED. HOWEVER, INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. A MITRACLIP XTW WAS INSERTED AND WAS ADVANCED UNDER THE MITRAL VALVE. HOWEVER, A GRIPPER BECAME CAUGHT ON THE ANTERIOR LEAFLET. TROUBLESHOOTING WAS PERFORMED THAT THE CLIP WAS ABLE TO BE FREED FROM THE LEAFLET. THE CLIP WAS INVERTED AND BROUGHT BACK TO THE LEFT ATRIUM (LA) AND THE GRIPPERS WERE RETESTED. HOWEVER, IT WAS OBSERVED THAT THE ANTERIOR SIDE GRIPPER WOULD NOT DEPLOY. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUES CONTINUED TO OCCUR. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. ONE CLIP WAS THEN DEPLOYED ON THE MITRAL VALVE, REDUCING THE MR TO A GRADE OF 1. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1743924 MITRACLIP G4 CLIP DELIVERY SYSTEM (MDR) MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40115A1001 05415067037381

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STEERABLE GUIDE CATHETER