BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3760128 · Received April 18, 2014

    Report

    Report Number
    2024168-2014-02482
    Event Type
    Death
    Date Received
    April 18, 2014
    Date of Event
    May 1, 2011
    Report Date
    February 27, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE INCIDENT INFORMATION WAS REVIEWED. IN THIS CASE, THERE WERE NO REPORTED DEVICE MALFUNCTIONS, AND THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE MITRACLIP PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND ITS RELATIONSHIP TO THE DEVICE, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO THE MANUFACTURING, DESIGN, OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    THIS EVENT WAS CAPTURED BASED ON LITERATURE REVIEW OF THE ARTICLE: MITRACLIP IMPLANTATION FOR HIGH RISK PATIENTS WITH SEVERE MITRAL REGURGITATION: THE SHEBA EXPERIENCE. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THAT THE MITRACLIP SYSTEM MAY BE RELATED TO A PATIENT DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED MITRACLIP IMPLANTATION FOR HIGH RISK PATIENTS WITH SEVERE MITRAL REGURGITATION: THE SHEBA EXPERIENCE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    237534 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death CONCOMITANT MEDICAL DEVICES