BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 16460354 · Received March 1, 2023

    Report

    Report Number
    2135147-2023-00926
    Event Type
    Injury
    Date Received
    March 1, 2023
    Date of Event
    January 6, 2023
    Report Date
    March 1, 2023
    Manufacturer
    ABBOTT MEDICAL
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD AND SIMILAR COMPLAINT REVIEW COULD NOT BE PERFORMED AS THE PART AND LOT NUMBER REGARDING THE COMPLAINT DEVICE WAS NOT PROVIDED. THE INVESTIGATION WAS UNABLE TO DETERMINE A CAUSE FOR THE REPORTED RECURRENT MITRAL REGURGITATION (MR), MITRAL STENOSIS, AND HEART FAILURE. RECURRENT MR, MITRAL STENOSIS, AND HEART FAILURE ARE LISTED IN THE INSTRUCTIONS FOR USE (IFU) AS KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED HOSPITALIZATION WAS A RESULT OF CASE-SPECIFIC CIRCUMSTANCE. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. ATTACHMENT: ARTICLE TITLED ¿PROGNOSTIC VALUE OF MITRAL VALVE HEMODYNAMIC PARAMETERS OBTAINED BY INTRAPROCEDURAL ECHOCARDIOGRAPHY IN TRANSCATHETER EDGE-TO-EDGE REPAIR.¿

    Description of Event or Problem · 0

    THIS IS FILED TO REPORT HEART FAILURE, RECURRENT MITRAL REGURGITATION AND MITRAL STENOSIS IT WAS REPORTED THROUGH A RESEARCH ARTICLE THAT FROM 2013 TO 2020, 926 PATIENTS UNDERWENT A MITRACLIP PROCEDURE. AN IMPLANTED MITRACLIP MAY HAVE CAUSED OR CONTRIBUTED TO HEART FAILURE, RECURRENT MITRAL REGURGITATION, MITRAL STENOSIS, AND REHOSPITALIZATION. ADDITIONAL INFORMATION IS LISTED IN THE ATTACHED ARTICLE, TITLED ¿PROGNOSTIC VALUE OF MITRAL VALVE HEMODYNAMIC PARAMETERS OBTAINED BY INTRAPROCEDURAL ECHOCARDIOGRAPHY IN TRANSCATHETER EDGE-TO-EDGE REPAIR.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    921342 MITRACLIP® SYSTEM CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT MEDICAL

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization