BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 1940684 · Received December 22, 2010

    Report

    Report Number
    3001743903-2010-00098
    Event Type
    Injury
    Date Received
    December 22, 2010
    Date of Event
    December 16, 2010
    Report Date
    December 22, 2010
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, THE PT PRESENTED WITH SHORTNESS OF BREATH AND INITIAL ECHOES SHOWED THE VALVE APPEARED TO BE FINE; HOWEVER, THE TRANSVALVULAR GRADIENT WAS ELEVATED. THE VALVE WAS EXPLANTED AND THE PHYSICIAN NOTICED THROMBUS ON 2 OF THE LEAFLETS THAT MAY HAVE CAUSED THE STENOSIS. ANOTHER 23 MM VALVE FROM ANOTHER MFR WAS IMPLANTED. ADD'L INFO HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. ESP100-23-00

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R