BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 22297304 · Received June 20, 2025

    Report

    Report Number
    2135147-2025-03311
    Event Type
    Malfunction
    Date Received
    June 20, 2025
    Date of Event
    May 28, 2025
    Report Date
    July 25, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NKM
    UDI-DI
    05415067050779
    PMA / PMN Number
    P100009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IN THIS CASE, THE RETURNED DEVICE ANALYSIS WAS UNABLE TO CONFIRM THE REPORTED DIFFICULT TO OPEN THE CLIP; HOWEVER, A CLIP ACTUATION WAS CONFIRMED AS THE CLIP WAS ABLE TO UNLOCK BUT WAS UNABLE TO OPEN PAST 180 DEGREES. THE REPORTED LEAK/SPLASH WAS CONFIRMED. ADDITIONALLY, IT WAS NOTED THAT THE ACTUATOR MANDREL WAS BENT BETWEEN THE ARM POSITIONER AND THE SEPTUM, MANDREL. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO SIMILAR COMPLAINTS REPORTED FROM THE LOT. THE INVESTIGATION DETERMINED THAT THE CLIP ACTUATION ISSUES ASSOCIATED WITH DIFFICULTY AND INABILITY OPENING THE CLIP, ALONG WITH THE REPORTED AND OBSERVED LEAKS AND THE OBSERVED BENT ACTUATOR MANDREL, MAY BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE; THEREFORE, THIS COMPLAINT WAS ADDED TO EXCEPTION (ISSUE) 134969 FOR FURTHER INVESTIGATION. 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 THIS WAS A MITRACLIP PROCEDURE TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. THE CLIP WAS PREPARED PER THE INSTRUCTIONS FOR USE (IFU) AND INSERTED INTO THE LEFT ATRIUM WITHOUT ANY ISSUES. UPON THE INITIAL CLIP OPENING IN THE LEFT ATRIUM, THE CLIP WOULD NOT OPEN. TROUBLESHOOTING WAS PERFORMED AND THE CLIP WAS ABLE TO OPEN. AFTER SUCCESSFULLY UNLOCKING AND OPENING THE CLIP, A LEAK WAS OBSERVED FROM THE BOTTOM FLUSH PORT, WHERE THE FLUSH LINE WAS CONNECTED, AS WELL AS THE ACTUATOR KNOB. DROPS WERE SEEN FORMING ON TOP OF THE LOCK KNOB VOLUME (LKF). THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. ONE CLIP WAS THEN IMPLANTED, 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
    1780542 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0801-XTW 50325R1097 05415067050779

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Male STEERABLE GUIDE CATHETER.