BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1020591 · Received March 28, 2008

    Report

    Report Number
    2953161-2008-00058
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    March 12, 2008
    Report Date
    March 27, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ALSO IMPLANTED IN THE PT (PCC141400/LOT#023431804 AND PCL161407/LOT#030924210). ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE REFER TO PMA SUPPLEMENT.

    Description of Event or Problem · 1

    AS REPORTED, IN 2003, THIS PT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES FOR AN ABDOMINAL AORTIC ANEURYSM. AT AN UNK DATE ANEURYSM ENLARGEMENT WAS OBSERVED. THERE WERE NO IDENTIFIABLE ENDOLEAKS OBSERVED ON IMAGING. IN 2008, THIS PT UNDERWENT A REINTERVENTION IN WHICH THE LEFT HYPOGASTRIC WAS COILED AND THE CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND THE ENDOPROSTHESIS DISTALLY. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 021231603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention