BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 3062931 · Received April 12, 2013

    Report

    Report Number
    3009024882-2013-00010
    Event Type
    Injury
    Date Received
    April 12, 2013
    Date of Event
    March 14, 2013
    Report Date
    April 9, 2013
    Manufacturer
    ST. JUDE MEDICAL COSTA RICA LTDA. (CS)
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE PT DEVELOPED ENDOCARDITIS AND UNDERWENT RE-DO AORTIC VALVE REPLACEMENT. A PREOPERATIVE ECHOCARDIOGRAM REVEALED THE VALVE WAS HEAVILY CALCIFIED WITH AN ELEVATED GRADIENT. CALCIFICATION WAS CONFIRMED AT EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    159121 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST. JUDE MEDICAL COSTA RICA LTDA. (CS) E100-25A

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R