BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 20278661 · Received September 23, 2024

    Report

    Report Number
    2135147-2024-04661
    Event Type
    Injury
    Date Received
    September 23, 2024
    Date of Event
    August 27, 2024
    Report Date
    September 23, 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 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 AND DUE TO THE LIMITED INFORMATION AVAILABLE FROM THE ARTICLE, THE REPORTED OFF-LABEL USE IS RELATED TO THE DEVICE BEING USED ON THE TRICUSPID VALVE. A CAUSES FOR THE REPORTED MITRAL VALVE REGURGITATION COULD NOT BE CONCLUSIVELY DETERMINED. THE REPORTED PATIENT EFFECT OF MITRAL VALVE REGURGITATION, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. B3: DATE OF EVENT ESTIMATED D4: THE UDI IS UNKNOWN DUE TO THE PART/LOT NUMBER WAS NOT PROVIDED D6: DATE OF IMPLANT ESTIMATED LITERATURE ATTACHMENT: ARTICLE TITLE ¿MITRAL REGURGITATION EVOLUTION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS-A SUB-ANALYSIS OF THE TRICVALVE REGISTRY."

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT BETWEEN 2010 AND 2023, 289 PATIENTS UNDERWENT A MITRACLIP OR TRICLIP PROCEDURE TO TREAT TRICUSPID REGURGITATION (TR). THE STUDY WAS PERFORMED TO ASSESS THE EVOLUTION OF MR AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS (TTVI) AND TO IDENTIFY PREDICTORS OF MITRAL REGURGITATION (MR) WORSENING AND IMPROVEMENT. THE MITRACLIP AND/OR TRICLIP MAY HAVE CAUSED OR CONTRIBUTED TO RECURRENT MR. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿MITRAL REGURGITATION EVOLUTION AFTER TRANSCATHETER TRICUSPID VALVE INTERVENTIONS-A SUB-ANALYSIS OF THE TRICVALVE REGISTRY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1488630 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other