BEUDAMED
    FDA Adverse Event Death Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 8122874 · Received December 1, 2018

    Report

    Report Number
    2024168-2018-09194
    Event Type
    Death
    Date Received
    December 1, 2018
    Date of Event
    May 8, 2017
    Report Date
    February 5, 2019
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UDI - THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE LOT HISTORY RECORD (LHR) FOR THIS PRODUCT COULD NOT BE REVIEWED BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER WAS NOT REPORTED. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE CLIP DELIVERY SYSTEM (CDS). THE REPORTED PATIENT EFFECT OF DEATH, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE IS A KNOWN POSSIBLE COMPLICATION ASSOCIATED WITH MITRACLIP PROCEDURES. BASED ON THE INFORMATION REVIEWED, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S), AND THE RELATIONSHIP TO THE PRODUCT, 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). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS NOT RETURNING FOR ANALYSIS. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. REPRESENTS THE MEAN PATIENT DEMOGRAPHICS REPORTED IN THE ATTACHED ARTICLE. ESTIMATED DATE. ATTACHMENT: EFFECT OF ATRIAL FIBRILLATION AND MITRAL VALVE GRADIENTS ON RESPONSE TO PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM, AMERICAN JOURNAL OF CARDIOLOGY 2018; 122:1371 - 1378 RALF WESTENFELD, MD, ET AL.

    Description of Event or Problem · 1

    THIS REPORT IS FILED FOR DEATH POST MITRACLIP IMPLANTATION. IT WAS REPORTED THROUGH A RESEARCH ARTICLE IDENTIFYING THE MITRACLIP THAT MAY BE RELATED TO DEATH. SPECIFIC PATIENT INFORMATION IS DOCUMENTED AS UNKNOWN. DETAILS ARE LISTED IN THE ATTACHED ARTICLE, TITLED: "EFFECT OF ATRIAL FIBRILLATION AND MITRAL VALVE GRADIENTS ON RESPONSE TO PERCUTANEOUS MITRAL VALVE REPAIR WITH THE MITRACLIP SYSTEM".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    961868 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death