BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 20336677 · Received September 30, 2024

    Report

    Report Number
    2135147-2024-04801
    Event Type
    Death
    Date Received
    September 30, 2024
    Date of Event
    August 31, 2024
    Report Date
    September 30, 2024
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    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. THE LOT HISTORY RECORD (LHR) REVIEW WAS NOT PERFORMED BECAUSE THIS INCIDENT WAS BASED ON AN ARTICLE REVIEW AND NO LOT INFORMATION WAS PROVIDED. BASED ON AVAILABLE INFORMATION, THE CAUSE OF THE REPORTED DEATH WAS UNABLE TO BE DETERMINED. THE REPORTED PATIENT EFFECT OF DEATH, 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. B2: DATE OF DEATH ESTIMATED. 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 ¿TRANSCATHETER REPAIR VERSUS MITRAL-VALVE SURGERY FOR SECONDARY MITRAL REGURGITATION.¿

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT BETWEEN FEBRUARY 2015 THROUGH DECEMBER 2022, 104 PATIENTS UNDERWENT A MITRACLIP PROCEDURE TO TREAT MITRAL REGURGITATION (MR). THE MITRACLIP MAY HAVE CAUSED OR CONTRIBUTED TO DEATH. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿TRANSCATHETER REPAIR VERSUS MITRAL-VALVE SURGERY FOR SECONDARY MITRAL REGURGITATION.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2607375 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death