BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 23661093 · Received November 26, 2025

    Report

    Report Number
    2135147-2025-06998
    Event Type
    Malfunction
    Date Received
    November 26, 2025
    Date of Event
    November 4, 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 IS NOT RETURNING 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 THAT ON (B)(6) 2025, A PATIENT PRESENTED WITH GRADE 3 FUNCTIONAL MITRAL REGURGITATION (MR) AND ENLARGED ATRIUM FOR A MITRACLIP PROCEDURE. DURING PREPARATION OF THE MITRACLIP, THERE WAS CHALLENGES DE-AIRING THE SYSTEM PER IFU INSTRUCTIONS. TROUBLESHOOTING WAS PREFORMED BY MOVING THE CDS FROM A HORIZONTAL POSITION TO A VERTICAL POSITION AND AIR WAS VISUALIZED RUNNING THROUGH THE CDS SLEEVE SHAFT. THEN THE CDS HANDLE WAS MOVED IN THE VERTICAL POSITION AND TRANSLATED A FEW TIMES BEFORE NO AIR WAS VISUALIZED. DURING THE PROCEDURE, THE MITRACLIP WAS SUCCESSFULLY IMPLANTED. THE FINAL MR WAS GRADE 1. THERE WERE NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAYS REPORTED.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1957920 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0802-XTW 50730R2024 05415067050755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown