BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED TISSUE VALVE

    MDR report key: 1034000 · Received April 25, 2008

    Report

    Report Number
    3001743903-2008-00019
    Event Type
    Injury
    Date Received
    April 25, 2008
    Date of Event
    February 18, 2008
    Report Date
    April 25, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, TWO MONTHS POSTOPERATIVELY, THE VALVE WAS EXPLANTED DUE TO TISSUE FORMATION LEADING TO STENOSIS. THE PT WAS NOT TAKING ANTICOAGULANTS AS PRESCRIBED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED TISSUE VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA EL-23A

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention