BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE RING

    MDR report key: 5810497 · Received July 20, 2016

    Report

    Report Number
    2025587-2016-01107
    Event Type
    Injury
    Date Received
    July 20, 2016
    Date of Event
    November 1, 2015
    Report Date
    June 22, 2016
    Manufacturer
    MEDTRONIC HEART VALVES DIVISION
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    TITLE: ASSESSMENT OF MITRAL ANNULOPLASTY RING BY CARDIAC COMPUTED TOMOGRAPHY: CORRELATION WITH ECHOCARDIOGRAPHIC PARAMETERS AND COMPARISON BETWEEN TWO DIFFERENT RING TYPES CITATION: THE JOURNAL OF THORACIC AND CARDIOVASCULAR SURGERY 2015 VOLUME 150(5):1082-90 (DOI 10.1016/J.JTCVS.2015.07.019) AUTHORS: YOUNG JOO SUH, MD, BYUNG-CHUL CHANG, MD, PHD, DONG JIN IM, MD, YUN JUNG KIM, MD, YOO JIN HONG, MD, GEU-RU HONG, MD, PHD, AND YOUNG JIN KIM, MD, PHD MONTH AND YEAR OF PUBLISH USED FOR EVENT DATE. NO UNIQUE DEVICE IDENTIFIER (SERIAL/LOT) NUMBERS WERE PROVIDED; WITHOUT THIS INFORMATION, IT CANNOT BE DETERMINED WHETHER THIS EVENT HAS 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 REVIEW REGARDING THE ASSESSMENT OF MITRAL ANNULOPLASTY RINGS BY CARDIAC COMPUTED TOMOGRAPHY. ALL DATA WERE COLLECTED FROM A SINGLE CENTER BETWEEN JANUARY 1995 AND AUGUST 2005. THE RETROSPECTIVE STUDY POPULATION INCLUDED 45 PATIENTS (PREDOMINANTLY MALE; MEAN AGE 57.2 YEARS), 18 OF WHICH WERE IMPLANTED WITH MEDTRONIC DURAN MITRAL ANNULOPLASTY RING (SERIAL NUMBERS NOT PROVIDED). AMONG ALL PATIENTS WITH THIS MITRAL ANNULOPLASTY RING, ADVERSE EVENTS INCLUDED: 1 INCIDENT OF SEVERE PARAVALVULAR LEAK (PVL), 18 INCIDENTS OF PANNUS, 9 INCIDENTS OF STENOSIS AND SUBSEQUENT INCREASED GRADIENT MEASUREMENTS (> 5 MM HG). THREE RE-OPERATIONS WERE REPORTED ONE DUE TO STENOSIS, AND TWO RE-OPERATIONS DUE TO DETACHMENT OF THE RING. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462452 DURAN ANCORE RING RING, ANNULOPLASTY KRH MEDTRONIC HEART VALVES DIVISION 620R

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention