BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIMULUS FLEXIBLE BAND

    MDR report key: 5743480 · Received June 22, 2016

    Report

    Report Number
    2025587-2016-00924
    Event Type
    Injury
    Date Received
    June 22, 2016
    Date of Event
    March 19, 2016
    Report Date
    May 26, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K052899
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: ROBERTS W ET AL. MITRAL VALVE REPLACEMENT AFTER FAILED MITRAL RING INSERTION WITH OR WITHOUT LEAFLET/CHORDAL REPAIR FOR PURE MITRAL REGURGITATION. AM J CARDIOL. 2016 JUN 1;117(11):1790-807. DATE OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION IT COULD NOT BE DETERMINED WHETHER THESE OBSERVATIONS HAVE BEEN PREVIOUSLY REPORTED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION VIA LITERATURE REGARDING UNFORTUNATE CONSEQUENCES OF MITRAL VALVE REPAIR WITH RING OR BAND IMPLANTATION. THE STUDY POPULATION INCLUDED 29 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 61 YEARS), FOUR OF WHICH WERE IMPLANTED WITH MEDTRONIC DURAN RING AND ONE OF WHICH WAS IMPLANTED WITH MEDTRONIC ATS SIMULUS SEMI-RIGID BAND. THE SERIAL NUMBERS WERE NOT PROVIDED. PATIENT 10: A (B)(6) MALE WITH SYSTEMIC HYPERTENSION AND SECONDARY FUNCTIONAL MITRAL REGURGITATION WAS IMPLANTED WITH A 38-MM SIMULUS SEMI-RIGID BAND. ONE YEAR POST-IMPLANT, THE PATIENT WAS NOTED WITH A DEHISCED RING, LEAFLET REPAIR BREAKDOWN, AND RESTRICTED POSTERIOR MITRAL LEAFLET. A MECHANICAL VALVE WAS IMPLANTED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED REGARDING MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    395228 SIMULUS FLEXIBLE BAND RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 700FC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R