BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 23097967 · Received September 19, 2025

    Report

    Report Number
    2135147-2025-05301
    Event Type
    Malfunction
    Date Received
    September 19, 2025
    Date of Event
    August 26, 2025
    Report Date
    December 11, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NKM
    UDI-DI
    05415067050755
    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

    THE DEVICE REMAINS IMPLANTED IN PATIENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR 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 OTHER COMPLAINTS REPORTED TO THIS LOT AND APPEAR TO BE RELATED TO A POTENTIAL PRODUCT QUALITY ISSUE. BASED ON AVAILABLE INFORMATION, THE INVESTIGATION DETERMINED THE REPORTED DIFFICULT TO FLUSH TO BE POTENTIALLY RELATED TO A 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, THIS INCIDENT IS POINTING TO EXCEPTION (ISSUE) 136179 AND EXCEPTION (ACTION) 142561. 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 BEING PERFORMED TO ADDRESS GRADE 3 FUNCTIONAL MITRAL REGURGITATION (MR). AFTER FLUSHING THE SYSTEM, THE CLIP WAS TESTED. DOING THE LAST FEW MOVEMENTS OF THE CLIP TESTING, SPECIFICALLY, RETRACTING THE CLIP DELIVERY SYSTEM (CDS), AIR WAS PASSING THROUGH THE CDS AGAIN. SEVERAL ADDITIONAL ADVANCE/RETRACT MOVEMENTS WERE SLOWLY PERFORMED TO COMPLETELY DEAIR THE SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593109 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0802-XTW 50505R1114 05415067050755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown