BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MITRACLIP G5 DELIVERY SYSTEM

    MDR report key: 23575936 · Received November 17, 2025

    Report

    Report Number
    2135147-2025-06717
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    October 23, 2025
    Report Date
    December 19, 2025
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NKM
    UDI-DI
    05415067050854
    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 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 CAUSE OF THE REPORTED RESISTANCE AND DIFFICULT TO INSERT CDS INTO SGC WERE UNABLE TO BE DETERMINED. 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

    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

    IT WAS REPORTED THAT ON (B)(6) 2025, A MITRACLIP PROCEDURE WAS PERFORMED TO TREAT DEGENERATIVE MITRAL REGURGITATION (MR) WITH A GRADE OF 4+. DURING THE PREPARATION OF BOTH THE XTW AND NTW CLIP, DE-AIRING THE DEVICES WAS DIFFICULT. ADDITIONAL DILATATIONS AND TURNING THE DEVICE VERTICALLY WERE PERFORMED TO DE-AIR THE DEVICES. THE XTW CLIP WAS SUCCESSFULLY IMPLANTED. WHILE INSERTING THE NTW INTO THE STEERABLE GUIDE CATHETER (SGC), RESISTANCE WAS FELT AND WAS UNABLE TO BE ADVANCED INTO THE STABILIZER FOR THE LAST CENTIMETER. THE CLIP WAS IMPLANTED, REDUCING MR 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
    2315757 MITRACLIP G5 DELIVERY SYSTEM MITRAL VALVE REPAIR DEVICES NKM ABBOTT VASCULAR INC. CDS0802-NTW 50611R2006 05415067050854

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown