BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TORONTO STENTLESS PORCINE VALVE

    MDR report key: 1003278 · Received February 27, 2008

    Report

    Report Number
    8020430-2008-00004
    Event Type
    Injury
    Date Received
    February 27, 2008
    Date of Event
    December 6, 2007
    Report Date
    February 27, 2008
    Manufacturer
    ST. JUDE MEDICAL CANADA, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE BIOPROSTHESIS WAS EXPLANTED AFTER 9 YEARS DUE TO DETERIORATION AND REPLACED WITH ANOTHER SJM VALVE. UPON INSPECTION OF THE VALVE AT TIME OF EXPLANT, IT WAS REVEALED THAT THE RIGHT CORONARY CUSP OF THE VALVE HAD BEEN TORN. THE LEAFLETS WERE RESECTED AND THE PREVIOUSLY PLACED FRAME OF THE STENTLESS VALVE WAS LEFT INTACT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TORONTO STENTLESS PORCINE VALVE TORONTO STENTLESS VALVE LWR ST. JUDE MEDICAL CANADA, INC. SPA-101-25

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R