BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2200785 · Received July 29, 2011

    Report

    Report Number
    2953161-2011-00167
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    February 7, 2011
    Report Date
    July 28, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: 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. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2004, THIS PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. ON AN UNKNOWN DATE, FOLLOW-UP IMAGING IDENTIFIED A TYPE IV ENDOLEAK. ON (B)(6) 2011, FOLLOW-UP IMAGING IDENTIFIED A TYPE IV ENDOLEAK AND ANEURYSM ENLARGEMENT TO 66 X 70 MM, COMPARED TO 61 X 67 MM IN 2007. ON (B)(6) 2011, AN INTERVENTION WAS PERFORMED TO TREAT THE TYPE IV ENDOLEAK WHEREBY TWO CONTRALATERAL LEG COMPONENTS WERE IMPLANTED. THE ENDOTENSION REPORTEDLY RESOLVED, AND THE PATIENT IS DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. WLG325 031043003

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R TETRAZEPAM| METOPROLOL| LOPID| LEVOXYL| PROTONIX| REGLAN| CRESTOR