BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1359535 · Received April 8, 2009

    Report

    Report Number
    2017233-2009-00185
    Event Type
    Injury
    Date Received
    April 8, 2009
    Date of Event
    October 26, 2005
    Report Date
    April 3, 2009
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICE IMPLANTED. PXC 141000.

    Description of Event or Problem · 1

    IN 2004, THE PT UNDERWENT AN ENDOVASCULAR PROCEDURE WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES. ON AN UNK DATE, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED. IN 2005, THE PT UNDERWENT A SECOND ENDOVASCULAR PROCEDURE WHERE A GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED. THE ENDOLEAK WAS RESOLVED. THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325 03253845

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R