BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1872078 · Received October 11, 2010

    Report

    Report Number
    2953161-2010-00183
    Event Type
    Injury
    Date Received
    October 11, 2010
    Date of Event
    September 20, 2010
    Report Date
    October 8, 2010
    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 SPECIFICATIONS. ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SERIOUS 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) 2004, THIS PT WAS IMPLANTED WITH GORE BIFURCATED AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, THE PT PRESENTED TO THE EMERGENCY ROOM. A CT SCAN REVEALED ANEURYSM ENLARGEMENT WITHOUT EVIDENCE OF AN ENDOLEAK. ON (B)(6) 2010, THE PT UNDERWENT ENDOVASCULAR REPAIR TO RELINE THE DEVICES. THE PT WAS IMPLANTED WITH AN AORTIC EXTENDED COMPONENT AND TWO ILIAC EXTENDER COMPONENTS. THE PT TOLERATED THE PROCEDURE AND NO FURTHER COMPLICATIONS HAVE BEEN REPORT.

    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 WLG325 022492106

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R