BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FREESTYLE AORTIC ROOT BIOPROSTHESIS

    MDR report key: 1658647 · Received April 7, 2010

    Report

    Report Number
    2025587-2010-00029
    Event Type
    Injury
    Date Received
    April 7, 2010
    Report Date
    March 10, 2010
    Manufacturer
    MEDTRONIC HEART VALVES, INC.
    Product Code
    LWR
    PMA / PMN Number
    P970031
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). DEVICE HISTORY RECORDS COULD NOT BE REVIEWED AS NO SERIAL NUMBERS WERE PROVIDED. RESULTS: NO PRODUCT WAS RETURNED. CONCLUSION: CAUSE OF EVENT CANNOT BE DETERMINED. NO PRODUCT WAS RETURNED. DUE TO THE LIMITED AMOUNT OF INFORMATION PROVIDED, THE MECHANISM OF FAILURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED INFORMATION THROUGH A JOURNAL ARTICLE (EUROPEAN JOURNAL CLINICAL INVESTIGATION 2009; 39(6): 471-480) THAT 18 AORTIC ROOT BIOPROSTHETIC VALVES WERE EXPLANTED, 16 DUE TO REGURGITATION AND 2 DUE TO STENOSIS. THE MEAN AGE OF THE PATIENTS WAS (B) (6)YEARS AND THE MEAN TIME OF IMPLANT WAS 5.9 +/- 3 YEARS (11 MALE AND 7 FEMALE). AT EXPLANT ALL VALVES WERE ANALYZED BY IMMUNO-HISTOCHEMISTRY AND TRANSMISSION ELECTRON MICROSCOPY. THE AUTHORS CONCLUDE THAT THE RESULTS SUPPORT THE CONCEPT THAT LIPID-MEDIATED INFLAMMATORY MECHANISMS MAY CONTRIBUTE TO THE STRUCTURAL VALVE DYSFUNCTION (SVD) OF BIOPROSTHESIS.

    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 Other