BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2111771 · Received May 25, 2011

    Report

    Report Number
    2953161-2011-00122
    Event Type
    Injury
    Date Received
    May 25, 2011
    Date of Event
    May 2, 2011
    Report Date
    May 24, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    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 SPECS. 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.

    Description of Event or Problem · 1

    ON (B)(6) 2003, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER BIFURCATED ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2011, CT SHOWED ANEURYSM GROWTH OF APPROX 5 MM WITH NO EVIDENT ENDOLEAK AS COMPARED WITH CT OF (B)(6) 2009. THE PHYSICIAN IS PRESENTLY MONITORING THE PT.

    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 WLG425 022734205

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other (B)(4)