BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 3201484 · Received June 28, 2013

    Report

    Report Number
    3001743903-2013-00032
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 12, 2013
    Report Date
    June 13, 2013
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT PRESENTED WITH CENTRAL LEAKAGE OF THE AORTIC VALVE PROSTHESIS. THE EPIC VALVE WAS NOT EXPLANTED AND REPLACED BY A SMALLER 23 MM SJM REGENT MECHANICAL VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    296803 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. ESP100-25 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R