BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 1870963 · Received October 8, 2010

    Report

    Report Number
    8020430-2010-00008
    Event Type
    Injury
    Date Received
    October 8, 2010
    Date of Event
    September 10, 2010
    Report Date
    October 8, 2010
    Manufacturer
    ST. JUDE MEDICAL CANADA, INC.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT AORTIC VALVE REPLACEMENT AND CABG X2 PROCEDURE. POSTOPERATIVELY, THE PATIENT DEVELOPED DYSPNEA AND WAS ADMITTED TO THE HOSPITAL. THE VALVE WAS REMOVED DUE TO STENOSIS AND HIGH GRADIENT AND WAS REPLACED WITH ANOTHER MANUFACTURER'S VALVE. THE SJM VALVE WAS SENT TO THE HOSPITAL'S LAB AND RESULTS WERE NEGATIVE FOR ENDOCARDITIS. THE VALVE WAS DESTROYED AT THE HOSPITAL AND, THEREFORE, WILL NOT BE RETURNED. ADDITIONAL INFORMATION 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 CANADA, INC. ESP100-23

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R