BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SJM EPIC SUPRA STENTED PORCINE HEART VALVE

    MDR report key: 2792286 · Received October 12, 2012

    Report

    Report Number
    3001743903-2012-00062
    Event Type
    Injury
    Date Received
    October 12, 2012
    Date of Event
    September 14, 2012
    Report Date
    September 17, 2012
    Manufacturer
    ST JUDE MEDICAL BRASIL LTDA.
    Product Code
    LWR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THIS INVESTIGATION ARE INCONCLUSIVE SINCE THE VALVE REMAINS IMPLANTED. THERE WAS NO EVIDENCE FOUND TO SUGGEST THERE WAS AN INTRINSIC DEFECT IN THE VALVE, AS SUPPORTED BY REVIEW OF THE VALVE'S DEVICE HISTORY RECORD. THE CAUSE OF THE REPORTED THROMBUS CAUSING THE HIGH GRADIENT REMAINS UNK.

    Description of Event or Problem · 1

    THE PT WAS ADMITTED FOR AN ASCENDING AORTIC DISSECTION. INTRAOPERATIVELY, IT WAS NOTED THE AORTIC VALVE HAD THROMBUS FORMATION. AN ELEPHANT TRUNK PROCEDURE WAS PERFORMED AND DUE TO THIS DIFFICULT PROCEDURE, THE VALVE WAS NOT REPLACED; HOWEVER, THE THROMBUS WAS REMOVED. THE VALVE REMAINS IMPLANTED AND THE PT IS BEING CONSIDERED FOR PERMANENT WARFARIN MEDICATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SJM EPIC SUPRA STENTED PORCINE HEART VALVE STENTED TISSUE VALVE LWR ST JUDE MEDICAL BRASIL LTDA. ESP100-23

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R