BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 5743471 · Received June 22, 2016

    Report

    Report Number
    2025587-2016-00922
    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
    K960356
    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. 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 6: A (B)(6) YEAR-OLD MALE WITH MITRAL VALVE PROLAPSE HAD A 33-MM DURAN RING IMPLANTED 91 DAYS PRIOR TO THE MITRAL VALVE REPLACEMENT. THE PATIENT REQUIRED A MECHANICAL VALVE IMPLANT DUE TO LEAFLET REPAIR BREAKDOWN AND SEVERE MITRAL REGURGITATION. AT THE TIME OF THE REPLACEMENT, IT WAS REPORTED THAT THE MITRAL ANNULUS WAS DILATED, THE DISTANCE FROM THE MITRAL ANNULAR REGION TO THE DISTAL MARGIN OF ANTERIOR MITRAL LEAFLET WAS ELONGATED, AND FIBROUS TISSUE COVERED THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED REGARDING MEDTRONIC PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396654 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Life Threatening| R