BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20990266 · Received December 20, 2024

    Report

    Report Number
    2135147-2024-06523
    Event Type
    Malfunction
    Date Received
    December 20, 2024
    Date of Event
    November 28, 2024
    Report Date
    February 21, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    05415067037343
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6. CODE 1069 WAS REMOVED AND CODE 1562 WAS ADDED. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED SINGLE GRIPPER ACTUATION ISSUE AND DETACHED GRIPPER LINE WERE CONFIRMED VIA DEVICE ANALYSIS. ADDITIONALLY, THE CLIP COVER WAS OBSERVED TO BE TORN. THE REPORTED POSITIONING FAILURE LEAFLET GRASPING 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 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 CAUSE OF THE REPORTED UNABLE TO GRASP AND TORN CLIP COVER WERE UNABLE TO BE DETERMINED. THE INVESTIGATION DETERMINED THE DETACHED GRIPPER LINES 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.

    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

    IT WAS REPORTED THIS WAS A MITRACLIP PROCEDURE TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND AN ENLARGED ATRIUM. AN XTW CLIP WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED WITHOUT ISSUES. IT WAS NOTED THAT THE LEAFLETS WERE UNABLE TO BE GRASPED. AFTER SEVERAL GRASPING ATTEMPTS, IT WAS OBSERVED THAT ONE GRIPPER WAS NOT FUNCTIONING AS INTENDED. TROUBLESHOOTING WAS PERFORMED, BUT THE ISSUE WAS UNABLE TO BE RESOLVED. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. UPON REMOVAL OF THE CLIP, IT WAS NOTED THAT THE GRIPPER LINE WAS NO LONGER ATTACHED TO THE GRIPPER. ONE CLIP WAS THEN DEPLOYED, REDUCING MR TO A GRADE OF 1-2. 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
    2147471 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40911R2075 05415067037343

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STEERABLE GUIDE CATHETER