BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 1202918 · Received October 17, 2008

    Report

    Report Number
    3001743903-2008-00052
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 4, 2008
    Report Date
    October 17, 2008
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED, NINE DAYS POSTOPERATIVELY, WHILE STILL RECOVERING AT THE HOSP, THE PT DEVELOPED KIDNEY FAILURE. AN ECHOCARDIOGRAM REVEALED VALVULAR INSUFFICIENCY. THE NEXT MORNING, THE PT ALSO DEVELOPED PULMONARY INSUFFICIENCY. THE VALVE WAS EXPLANTED AND DURING THE PROCEDURE, ONE LEAFLET WAS OBSERVED TO BE FLATTENED AND CONTAINED A CENTRAL TEAR APPROX 3 MM FROM THE NODE OF ARANTIUS. A PROSTHESIS FROM ANOTHER MFR WAS THEN IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED PORCINE HEART VALVE STENTED TISSUE VALVE. LWR ST JUDE MEDICAL BRASIL LTDA. E100-21A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R