BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC STENTED PORCINE HEART VALVE

    MDR report key: 2780530 · Received October 5, 2012

    Report

    Report Number
    3001743903-2012-00066
    Event Type
    Injury
    Date Received
    October 5, 2012
    Date of Event
    January 1, 2012
    Report Date
    September 10, 2012
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE VALVE WAS NOT RETURNED FOR ANALYSIS SINCE A VALVE IN VALVE PROCEDURE WAS PERFORMED. THE DEVICE HISTORY RECORD WAS ALSO UNABLE TO BE REVIEWED SINCE THE SERIAL NUMBER REMAINS UNKNOWN. THE CAUSE OF THE MITRAL REGURGITATION REMAINS UNKNOWN.

    Description of Event or Problem · 1

    THE INFORMATION PROVIDED TO SJM FROM A CLINICAL ABSTRACT: "SUCCESSFUL TRANSFEMORAL ANTEGRADE VALVE-IN-VALVE IMPLANTATION OF A SAPIEN XT VALVE INTO A DEGENERATED MITRAL VALVE PROSTHESIS" JOURNAL OF INVASIVE CARDIOLOGY 2012 24:4 (170-172) INDICATED THE PATIENT PRESENTED WITH REGURGITATION. A RE-DO MITRAL VALVE REPLACEMENT SURGERY WAS REFUSED BY THE PATIENT AND THE PATIENT WAS ALSO CONSIDERED AN EXTREMELY HIGH RISK BY THE CARDIAC SURGEON; THEREFORE, A TRANSFEMORAL VALVE-IN VALVE IMPLANTATION WAS PLANNED. INTRAOPERATIVELY A 26 MM VALVE FROM ANOTHER MANUFACTURER WAS IMPLANTED IN THE MITRAL POSITION. THE PATIENT WAS REPORTED TO BE RECOVERING. NO ADDITIONAL INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC STENTED PORCINE HEART VALVE NONE LWR ST JUDE MEDICAL BRASIL LTDA. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R