BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 19829657 · Received July 25, 2024

    Report

    Report Number
    2135147-2024-03593
    Event Type
    Injury
    Date Received
    July 25, 2024
    Date of Event
    April 1, 2021
    Report Date
    September 4, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CLIP REMAINS IN THE 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. B3: DATE OF EVENT ESTIMATED. D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED. D6: DATE OF IMPLANT ESTIMATED. H6: DEVICE CODE 1494 - INDICATION FOR USE (USE IN TRICUSPID VALVE). ATTACHMENT: ARTICLE TITLED ¿IMPACT OF LEAFLET-TO-ANNULUS INDEX ON RESIDUAL REGURGITATION FOLLOWING TRANSCATHETER EDGE-TO-EDGE REPAIR OF THE TRICUSPID VALVE"

    Additional Manufacturer Narrative · 0

    THE DEVICES WERE NOT RETURNED FOR ANALYSIS AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT IS BASED ON AN ARTICLE REVIEW, AND LOT/DEVICE INFORMATION IS NOT AVAILABLE. BASED ON AVAILABLE INFORMATION, THE REPORTED OFF-LABEL USE IS RELATED TO THE DEVICE BEING USED ON THE TRICUSPID VALVE. THE REPORTED UNCHANGED AND RECURRENT TRICUSPID REGURGITATION APPEAR TO BE RELATED TO CHALLENGING PATIENT ANATOMY (MISMATCH BETWEEN LEAFLET LENGTH AND ANNULUS DILATION). THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ARTICLE TITLED ¿IMPACT OF LEAFLET-TO-ANNULUS INDEX ON RESIDUAL REGURGITATION FOLLOWING TRANSCATHETER EDGE-TO-EDGE REPAIR OF THE TRICUSPID VALVE".

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT FROM APRIL 2021 TO MARCH 2024, 25 PATIENTS UNDERWENT A MITRACLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR). THE IMPLANTED MITRACLIP MAY HAVE CAUSE OR CONTRIBUTE TO UNCHANGED TR AND RECURRENT TR. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿IMPACT OF LEAFLET-TO-ANNULUS INDEX ON RESIDUAL REGURGITATION FOLLOWING TRANSCATHETER EDGE-TO-EDGE REPAIR OF THE TRICUSPID VALVE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229835 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other