BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3201525 · Received June 28, 2013

    Report

    Report Number
    3009024882-2013-00017
    Event Type
    Injury
    Date Received
    June 28, 2013
    Date of Event
    June 19, 2013
    Report Date
    June 19, 2013
    Manufacturer
    ST. JUDE MEDICAL
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PATIENT PRESENTED WITH A HIGH GRADIENT AND UNDERWENT A RE-DO AORTIC VALVE REPLACEMENT PROCEDURE. INTRAOPERATIVELY, THE SJM EPIC VALVE WAS FOUND TO BE THROMBOSED WITH GREYISH TISSUE ON THE OUTFLOW SIDE OF THE CUSP. THE VALVE WAS REMOVED AND REPLACED BY A 21 MM SJM TRIFECTA TISSUE VALVE. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION POSTOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    295381 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL E100-23A NA

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Hospitalization| R