BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1961393 · Received January 10, 2011

    Report

    Report Number
    2953161-2011-00005
    Event Type
    Injury
    Date Received
    January 10, 2011
    Date of Event
    October 25, 2010
    Report Date
    January 10, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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. PLEASE NOTE ADD'L DEVICES IMPLANTED AND RELATED TO THIS EVENT. (B)(4). 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 FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, A COMPUTED TOMOGRAPHY REVEALED 1.33CM OF ANEURYSM GROWTH. THE ANEURYSM IS MEASURING 6.9CM WITH A TYPE IV ENDOLEAK. THE PT IS SCHEDULED TO BE TREATED FOR THE ANEURYSM GROWTH AND THE TYPE IV ENDOLEAK BY IMPLANTING ADD'L DEVICES IN THE ABDOMINAL AORTIC ANEURYSM.

    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 031620908

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Other BABY ASPIRIN| ENALAPRIL MALEATE| HYDROCHLOROTHIAZIDE| THE PT'S MEDICATIONS INCLUDE: ATENOLOL| PLAVIX