BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MITRACLIP SYSTEM CLIP DELIVERY SYSTEM

    MDR report key: 6399636 · Received March 13, 2017

    Report

    Report Number
    2024168-2017-02060
    Event Type
    Injury
    Date Received
    March 13, 2017
    Date of Event
    February 8, 2017
    Report Date
    March 13, 2017
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NKM
    UDI-DI
    08717648195914
    PMA / PMN Number
    P100009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. DATE OF EVENT, RELEVANT TESTS/LAB DATA: ESTIMATED DATES 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 EFFECT OF MITRAL STENOSIS AND DYSPNEA, AS LISTED IN THE MITRACLIP SYSTEM INSTRUCTIONS FOR USE ARE KNOWN POSSIBLE COMPLICATIONS ASSOCIATED WITH MITRACLIP PROCEDURES. THE REPORTED DYSPNEA WAS LIKELY A SYMPTOM OR SECONDARY EFFECT OF THE MITRAL STENOSIS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT OF MITRAL STENOSIS 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.

    Description of Event or Problem · 1

    THIS REPORT IS FILED FOR THE MITRAL STENOSIS. IT WAS REPORTED THAT ONE MITRACLIP WAS IMPLANTED REDUCING MITRAL REGURGITATION (MR) GRADE FROM 3-4 TO TRACE. THE MEAN GRADIENT PRESSURE (MGP) AT THE END OF THE PROCEDURE WAS 9 MM HG. A FEW DAYS LATER, BEFORE THE PATIENT WAS DISCHARGED HOME, THE PATIENT HAD SHORTNESS OF BREATH. AN ECHOCARDIOGRAM FOUND THE MGP HAD INCREASED TO 17 MM HG, BUT NO INCREASE IN MR WAS NOTED. MEDICATION WAS ADJUSTED TO LOWER THE BLOOD PRESSURE AND HEART RATE AND SUBSEQUENTLY, THE MGP WAS REDUCED TO 12 TO 13 MM HG. THE PATIENT WILL REQUIRE SURGERY TO REPAIR THE MITRAL VALVE AND EXPLANT THE MITRACLIP. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    182024 MITRACLIP SYSTEM CLIP DELIVERY SYSTEM MITRACLIP DELIVERY SYSTEM NKM AV-TEMECULA-CT 60826U187 08717648195914

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention