BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 3760144 · Received April 18, 2014

    Report

    Report Number
    2024168-2014-02483
    Event Type
    Injury
    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). THE INCIDENT INFORMATION WAS REVIEWED. IN THIS CASE, THERE WERE NO REPORTED DEVICE MALFUNCTIONS ASSOCIATED WITH THE REPORTED INCIDENT, AND THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. THE REPORTED PATIENT EFFECTS OF STROKE (CEREBROVASCULAR ACCIDENT), FEVER, HEART FAILURE, AND PSEUDOANEURYSM, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE (IFU), ARE KNOWN POTENTIAL COMPLICATIONS ASSOCIATED WITH THE MITRACLIP PROCEDURE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE 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.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: MITRACLIP SYSTEM: STEERABLE GUIDE CATHETER, LIFT, SUPPORT PLATE, STABILIZER. THE PATIENT AGE IS ESTIMATED. DATE OF EVENT IS ESTIMATED. DATE OF IMPLANT IS ESTIMATED. THE MITRACLIP REMAINS IN THE ANATOMY. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. EDWARD KOIFMAN MD; PAUL FEFER MD; ILAN HAY MD; MICHA FEINBERG MD; ELAD MAOR MD; AND VICTOR GUETTA MD; (IMAJ 2014; 16: 91 95): MITRACLIP IMPLANTATION FOR HIGH RISK PATIENTS WITH SEVERE MITRAL REGURGITATION: THE SHEBA EXPERIENCE.

    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 PSEUDOANEURYSM, HEART FAILURE, AND INABILITY TO ACHIEVE A REDUCTION IN MR, WHICH MAY HAVE RESULTED IN PROLONGED HOSPITALIZATION AND TREATMENT WITH MEDICATION. 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
    237099 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Hospitalization| R