BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1211591 · Received October 23, 2008

    Report

    Report Number
    2017233-2008-00780
    Event Type
    Injury
    Date Received
    October 23, 2008
    Date of Event
    September 25, 2008
    Report Date
    October 22, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT/SERIAL NUMBER OF THE DEVICE IMPLANTED IN THIS PATIENT WAS NOT REPORTED TO GORE, HENCE A REVIEW OF THE MANUFACTURING PAPERWORK WAS UNABLE TO BE CONDUCTED.

    Description of Event or Problem · 1

    IN 2008, GORE BECAME AWARE OF A POSSIBLE ADVERSE EVENT ON THIS PATIENT. ON THE NEXT DAY, GORE BECAME AWARE THAT THE PATIENT'S COMMON ILIAC ARTERY WAS STARTING TO DILATE SPONTANEOUSLY. ON THE FOLLOWING MONTH, GORE BECAME AWARE THAT A REINTERVENTION WAS PERFORMED TO EXTEND THE GORE EXCLUDER AAA ENDOPROSTHESIS TO THE EXTERNAL ILIAC ARTERY. THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention