BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6191974 · Received December 20, 2016

    Report

    Report Number
    2024168-2016-09084
    Event Type
    Death
    Date Received
    December 20, 2016
    Date of Event
    October 4, 2011
    Report Date
    January 11, 2018
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CLIP REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT. THE REPORTED PATIENT EFFECTS OF WORSENING MITRAL REGURGITATION (MR) AND DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE, ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, A DEFINITIVE CAUSE FOR THE REPORTED PATIENT EFFECTS COULD NOT BE DETERMINED. 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 ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.

    Additional Manufacturer Narrative · 1

    (B)(4). DATE OF EVENT CAPTURES THE SEVERE MITRAL REGURGITATION AND WAS UPDATED FROM ESTIMATED (B)(6) 2013 TO (B)(6) 2011.

    Description of Event or Problem · 1

    THIS REPORT IS CONSERVATIVELY FILED FOR THE PATIENT DEATH. IT WAS REPORTED THAT ON (B)(6) 2009 THE MITRACLIP WAS IMPLANTED REDUCING MITRAL REGURGITATION (MR) FROM GRADE 3 TO 1-2. ON (B)(6) 2010, THE PATIENT HAD MODERATE MR ON ECHOCARDIOGRAM. ON AN UNKNOWN DATE THE PATIENT HAD SEVERE MR. THE PATIENT EXPIRED ON AN UNKNOWN DATE. THE PATIENT DEATH MAY POSSIBLY BE RELATED TO THE MITRACLIP DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE PREVIOUSLY FILED REPORT, ADDITIONAL INFORMATION WAS RECEIVED THAT THE SEVERE MITRAL REGURGITATION WAS FOUND ON THE TRANSTHORACIC ECHOCARDIOGRAM (B)(6) 2011. THE PATIENT EXPIRED ON (B)(6) 2013. BOTH OF THESE EVENTS OCCURRED PRIOR TO MITRACLIP COMMERCIAL APPROVAL IN THE US IN OCTOBER 2013 AND WERE REPORTED THROUGH THE CLINICAL TRIAL; HOWEVER, SINCE AN MDR WAS ALREADY FILED (THE EVENT DATES WERE PREVIOUSLY UNKNOWN), THIS WILL REMAIN MDR REPORTABLE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839292 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 090911A0303

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Death