BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20644853 · Received November 8, 2024

    Report

    Report Number
    2135147-2024-05634
    Event Type
    Malfunction
    Date Received
    November 8, 2024
    Date of Event
    October 14, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231018
    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

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED BROKEN GRIPPER LINE WAS NOT CONFIRMED VIA DEVICE ANALYSIS. THE REPORTED SINGLE GRIPPER ACTUATION ISSUE WAS CONFIRMED VIA DEVICE ANALYSIS. ADDITIONALLY, IT WAS OBSERVED THAT THE GRIPPER LINE WAS DETACHED. 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 REPORTED BROKEN GRIPPER LINE WAS DUE TO USER PERCEPTION. 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

    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 DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4. 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. A GRIPPER LINE BREAK WAS SUSPECTED. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. 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
    1815451 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40404R2075 08717648231018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STEERABLE GUIDE CATHETER