BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 23622024 · Received November 21, 2025

    Report

    Report Number
    2135147-2025-06842
    Event Type
    Malfunction
    Date Received
    November 21, 2025
    Date of Event
    October 29, 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
    AU
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    NA. 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.

    Description of Event or Problem · 0

    N/A.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP AND TRICLIP PROCEDURE WAS PERFORMED TO TREAT FUNCTIONAL MITRAL REGURGITATION (MR) WITH A GRADE OF 4 AND TRICUSPID REGURGITATION WITH A GRADE OF 5. DURING THE PREPARATION OF ONE CLIP DELIVERY SYSTEM (CDS) AND TWO TRICLIP DELIVERY SYSTEM (TCDS), DE-AIRING THE DEVICE WAS NOT POSSIBLE. ADDITIONAL TRANSLATIONS WERE REQUIRED TO FULLY DE-AIR THE DEVICES. IT WAS NOTED THAT THE STEERABLE GUIDE CATHETER (SGC) EXPERIENCED DIFFICULTIES INSERTING THROUGH THE ANATOMY. A KINK WAS OBSERVED AT THE DISTAL END OF THE SGC. THEREFORE, THE DEVICE WAS REMOVED AND REPLACED. THE CLIPS WERE THEN IMPLANTED, REDUCING MR TO A GRADE OF 1-2 AND TR TO A GRADE OF 2. 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
    2348001 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0802-XTW 50708R2113 05415067050755

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown