BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 1912645 · Received November 24, 2010

    Report

    Report Number
    2025587-2010-00149
    Event Type
    Injury
    Date Received
    November 24, 2010
    Report Date
    November 4, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL: DEVICE HISTORY WAS NOT REVIEWED AS NO SERIAL NUMBER WAS OBTAINED. RESULTS: NO PRODUCT WAS RETURNED JOURNAL ARTICLE. 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 INFO THROUGH A JOURNAL ARTICLE, IMAGING IN CARDIOLOGY, NETHERLANDS HEART JOURNAL, VOLUME 18, NUMBER 7/8, AUGUST 2010, THAT SIX MONTHS AFTER THE IMPLANT OF THIS BIOPROSTHETIC VALVE (ROOT REPLACEMENT - COMPLICATED BY A STERILE, PROBABLY BIOLOGICAL GLUE-INDUCED, MEDIASTINITIS), A PSEUDOANEURYSM OF THE ASCENDING AORTA WAS IDENTIFIED. THE ANEURYSM ORIGINATED FROM THE DISTAL CONNECTION OF THE PROSTHESIS. AN INTERPOSITION TUBE GRAFT WAS PLACED. THERE WAS NO ADVERSE PT EFFECTS.

    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