BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DURAN ANCORE BAND

    MDR report key: 7608459 · Received June 16, 2018

    Report

    Report Number
    2025587-2018-01504
    Event Type
    Injury
    Date Received
    June 16, 2018
    Date of Event
    March 1, 2015
    Report Date
    June 16, 2018
    Manufacturer
    HEART VALVES SANTA ANA
    Product Code
    KRH
    PMA / PMN Number
    K960356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CITATION: MCGRATH T DISSECTING INTRAMYOCARDIAL HEMATOMA AFTER ROBOTIC MITRAL VALVE REPAIR. ANN THORAC SURG. 2015 MAR;99(3):1048-51. DOI: 10.1016/J.ATHORACSUR.2014.04.134. EARLIEST 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. 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 A (B)(6) YEAR-OLD WOMAN WITH MEDICAL HISTORY OF SEVERE MITRAL REGURGITATION WHO UNDERWENT IMPLANTATION OF MEDTRONIC 33MM DURAN ANNULOPLASTY BAND. SUBSEQUENTLY, THE ANNULOPLASTY BAND WAS REPLACED WITH 27MM DURANBAND DUE TO MODERATE MITRAL REGURGITATION. THE SERIAL NUMBERS NOT PROVIDED. TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) REVEALED DISSECTING INTRAMYOCARDIAL HEMATOMA (DIH) WHICH WAS CONSERVATIVELY MANAGED WITH TRANSFUSIONS OF FRESH FROZEN PLASMA, PLATELETS, CRYOPRECIPITATE. NO ADDITIONAL ADVERSE PATIENT EFFECTS OR PRODUCT PERFORMANCE ISSUES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    450619 DURAN ANCORE BAND RING, ANNULOPLASTY KRH HEART VALVES SANTA ANA 620B

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Required Intervention