BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20051761 · Received August 23, 2024

    Report

    Report Number
    2135147-2024-04147
    Event Type
    Malfunction
    Date Received
    August 23, 2024
    Date of Event
    July 31, 2024
    Report Date
    September 5, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231018
    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

    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.

    Additional Manufacturer Narrative · 0

    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 MIXED MITRAL REGURGITATION (MR) WITH A GRADE OF 3 AND THIN LEAFLETS. AN XTW CLIP WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED WITHOUT ISSUES. HOWEVER, WHILE IN THE VALVE, 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, IT WAS OBSERVED THAT ONE OF THE GRIPPERS LINES HAD DISCONNECTED. ONE CLIP WAS THEN DEPLOYED, REDUCING 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
    1312563 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40416R1120 08717648231018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STEERABLE GUIDE CATHETER