BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 1853275 · Received September 29, 2010

    Report

    Report Number
    2025587-2010-00113
    Event Type
    Injury
    Date Received
    September 29, 2010
    Date of Event
    August 24, 2010
    Report Date
    September 1, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4), EVALUATION METHOD: DEVICE HISTORY COULD NOT BE REVIEWED AS THE SERIAL NUMBER WAS NOT PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. ANALYSIS: NO PRODUCT WAS RETURNED. CONCLUSION: WITHOUT THE RETURN OF THE PRODUCT, NO DEFINITIVE CONCLUSION CAN BE MADE REGARDING THE CLINICAL OBSERVATION.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THAT THIS BIOPROSTHETIC VALVE IMPLANTED 3 YEARS, WAS EXPLANTED DUE TO AORTIC REGURGITATION DUE TO A DILATED AORTIC ROOT (APPROXIMATELY 7 CM) AND PSEUDOANEURYSM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FREESTYLE AORTIC ROOT BIOPROSTHESIS LWR MEDTRONIC HEART VALVES, INC. 995 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention