BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP CLIP DELIVERY SYSTEM

    MDR report key: 9995281 · Received April 24, 2020

    Report

    Report Number
    2024168-2020-03870
    Event Type
    Injury
    Date Received
    April 24, 2020
    Date of Event
    October 1, 2009
    Report Date
    July 29, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 1

    EVENT DATES ESTIMATED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD AND A REVIEW OF THE COMPLAINT HISTORY COULD NOT BE PERFORMED AS THIS COMPLAINT WAS REPORTED THROUGH A RESEARCH ARTICLE AND SPECIFIC PATIENT AND CASE INFORMATION IS NOT AVAILABLE. BASED ON THE LIMITED AVAILABLE INFORMATION, A DEFINITE CAUSE FOR THE REPORTED MITRAL REGURGITATION CANNOT BE DETERMINED. THE REPORTED PATIENT EFFECT OF WORSENING MITRAL REGURGITATION (MR) AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. THERE IS NO INDICATION OF PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. ATTACHMENT: ARTICLE TITLED, WHAT IS A ¿¿GOOD¿¿ RESULT AFTER TRANSCATHETER MITRAL REPAIR? IMPACT OF 2+ RESIDUAL MITRAL REGURGITATION.

    Description of Event or Problem · 1

    THIS IS BEING FILED TO REPORT THE MITRAL REGURGITATION, RE-HOSPITALIZATION, SURGICAL INTERVENTION, AND RE-INTERVENTION PROCEDURES. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING MITRACLIP THAT MAY BE RELATED TO PATIENT MITRAL REGURGITATION, RE-HOSPITALIZATION, SURGICAL INTERVENTION, AND RE-INTERVENTION PROCEDURES. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, WHAT IS A ¿¿GOOD¿¿ RESULT AFTER TRANSCATHETER MITRAL REPAIR? IMPACT OF 2+ RESIDUAL MITRAL REGURGITATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    460047 MITRACLIP CLIP DELIVERY SYSTEM VALVE REPAIR NKM ABBOTT VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R