BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 22197703 · Received June 12, 2025

    Report

    Report Number
    2135147-2025-03121
    Event Type
    Malfunction
    Date Received
    June 12, 2025
    Date of Event
    May 19, 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
    NJ, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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

    IN THIS CASE, THE RETURNED DEVICE ANALYSIS DID NOT CONFIRM THE REPORTED DIFFICULTY OPENING THE CLIP (DIFFICULT TO OPEN OR CLOSE). THE REPORTED LEAK/SPLASH, HOWEVER, WAS CONFIRMED. ADDITIONALLY, IT WAS NOTED THAT THE ACTUATOR MANDREL WAS BENT AT THE REGION THAT GOES THROUGH 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 REPORTED DIFFICULTY OPENING THE CLIP, ALONG WITH THE REPORTED AND OBSERVED LEAK AND THE OBSERVED BENT ACTUATOR MANDREL, MAY BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. 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 DURING PREPARATION OF THE CLIP DELIVERY SYSTEM (CDS), A LEAK WAS OBSERVED ONCE THE DELIVERY CATHETER (DC) WAS TIPPED DOWNWARD. FLUID WAS OBSERVED LEAKING OUT AROUND THE LUER. UPON FURTHER INSPECTION, FLUID WAS OBSERVED ON THE INSIDE OF THE DC HANDLE CHAMBER, OUTSIDE OF THE LOCK KNOB VOLUME (LKV). THEREFORE, THE CDS WAS NOT USED AND WAS REPLACED. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1780384 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0801-XTW 50326R1014 05415067050779

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male