BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP

    MDR report key: 20440975 · Received October 14, 2024

    Report

    Report Number
    2135147-2024-05065
    Event Type
    Malfunction
    Date Received
    October 14, 2024
    Date of Event
    September 19, 2024
    Report Date
    January 16, 2025
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    UDI-DI
    08717648231018
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D4 - LOT # HAS BEEN CHANGED FROM 40709R1014 TO 40709R1019. D4 - CATALOG # HAS BEEN CHANGED FROM CDS0702-XTW TO CDS0702-XTW. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED POSITIONING FAILURE AND SINGLE GRIPPER ACTUATION ISSUE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. HOWEVER, THE GRIPPER LINES WERE OBSERVED TO HAVE SLIPPED FROM THEIR INTENDED LOCATION. 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 ISSUE. BASED ON AVAILABLE INFORMATION, THE REPORTED POSITIONING FAILURE IS A CASCADING EVENT OF THE SINGLE GRIPPER ACTUATION ISSUE. THE REPORTED SINGLE GRIPPER ACTUATION ISSUE IS DUE TO THE SLIPPED GRIPPER LINES, WHICH 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 ROOT CAUSE TO BE RELATED TO MANUFACTURING VARIABILITY WITHIN SPECIFICATIONS LEADING TO TOLERANCE STACK UP BETWEEN THE GRIPPER LINES, COUPLER, AND L-LOCK COMPONENTS. 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.

    Additional Manufacturer Narrative · 0

    ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND THE REPORTED POSITIONING FAILURE AND SINGLE GRIPPER ACTUATION ISSUE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT. HOWEVER, THE GRIPPER LINES WERE OBSERVED TO HAVE SLIPPED FROM THEIR INTENDED LOCATION. 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 ISSUE. BASED ON AVAILABLE INFORMATION, THE REPORTED POSITIONING FAILURE IS A CASCADING EVENT OF THE SINGLE GRIPPER ACTUATION ISSUE. THE REPORTED SINGLE GRIPPER ACTUATION ISSUE IS DUE TO THE SLIPPED GRIPPER LINES, WHICH WAS DETERMINED TO BE A POTENTIAL PRODUCT QUALITY ISSUE. THE INVESTIGATION EVALUATED THE REPORTED ISSUE, AND THE ENGINEERING GROUP DETERMINED THE ROOT CAUSE TO BE RELATED TO MANUFACTURING VARIABILITY WITHIN SPECIFICATIONS LEADING TO TOLERANCE STACK UP BETWEEN THE GRIPPER LINES, COUPLER, AND L-LOCK COMPONENTS. THE ISSUE 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 A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4. A MITRACLIP XTW WAS INSERTED, AND INDEPENDENT GRASPING WAS PERFORMED. HOWEVER, ON THE FOURTH INDEPENDENT GRASPING ATTEMPT, A SINGLE GRIPPER ACTUATION ISSUE OCCURRED. THEREFORE, THE CLIP WAS REMOVED AND REPLACED. TWO CLIPS WERE THEN DEPLOYED, REDUCING THE MR TO A GRADE OF 1. POST PROCEDURE, THE CLIP WAS HANDLED AS THERE WAS AN ATTEMPT TO RAISE AND THE LOWER THE GRIPPERS OUTSIDE THE PATIENT. 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
    2244063 MITRACLIP MITRAL VALVE REPAIR DEVICES NKM ABBOTT MEDICAL 40709R1019 08717648231018

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown STEERABLE GUIDE CATHETER.