BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 10012303 · Received April 29, 2020

    Report

    Report Number
    2024168-2020-04009
    Event Type
    Injury
    Date Received
    April 29, 2020
    Date of Event
    December 1, 2018
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS RESUBMITTED TO ENSURE THE ENCLOSED ATTACHMENT CAN BE EASILY OPENED BY THE FDA. ARTICLE ATTACHMENT: "THE IMPACT OF RESIDUAL MITRAL REGURGITATION AFTER MITRACLIP THERAPY IN FUNCTIONAL MITRAL REGURGITATION". ATTACHMENT: [ARTICLE CN-030439.PDF].

    Additional Manufacturer Narrative · 1

    DATE OF EVENT - ESTIMATED. THE UNIQUE DEVICE IDENTIFIER (UDI) IS UNKNOWN BECAUSE THE PART AND LOT NUMBERS WERE NOT PROVIDED. IMPLANT DATE - ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS AND A REVIEW OF THE LOT HISTORY RECORD COULD NOT BE PERFORMED AS THE PART AND LOT INFORMATION WAS NOT PROVIDED. THE REPORTED PATIENT EFFECTS OF MITRAL REGURGITATION, HEART FAILURE, CARDIAC TAMPONADE AND TISSUE DAMAGE, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, IS A KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. ALL AVAILABLE INFORMATION WAS INVESTIGATED, AND A DEFINITIVE CAUSE FOR THE REPORTED POSITIONING FAILURE AND REPORTED PATIENT MITRAL REGURGITATION, HEART FAILURE, CARDIAC TAMPONADE, TISSUE DAMAGE COULD NOT BE DETERMINED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT ISSUE WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. THE PATIENT DEATHS ARE FILED UNDER A SEPARATE MFR NUMBER. ATTACHED ARTICLE, TITLED ¿THE IMPACT OF RESIDUAL MITRAL REGURGITATION AFTER MITRACLIP THERAPY IN FUNCTIONAL MITRAL REGURGITATION." (B)(4).

    Description of Event or Problem · 1

    THIS IS FILED TO REPORT SERIOUS INJURIES. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP DEVICE THAT MAY BE RELATED TO THE FOLLOWING: PATIENT DEATHS, MITRAL REGURGITATION, HEART FAILURE, CARDIAC TAMPONADE, CARDIOPULMONARY RESUSCITATION, RE-HOSPITALIZATION, MEDICAL INTERVENTION, AND SURGICAL INTERVENTION. DEVICE ISSUES INCLUDE, UNABLE TO GRASP THE LEAFLETS. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED ¿THE IMPACT OF RESIDUAL MITRAL REGURGITATION AFTER MITRACLIP THERAPY IN FUNCTIONAL MITRAL REGURGITATION." PLEASE SEE ARTICLE FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    475598 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| L| R| S