BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1821209 · Received August 27, 2010

    Report

    Report Number
    2953161-2010-00157
    Event Type
    Injury
    Date Received
    August 27, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 27, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED AND RELATED TO THIS EVENT. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2003, THE PATIENT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010, A COMPUTED TOMOGRAPHY REVEALED 3 CM OF ANEURYSM GROWTH AND A TYPE II ENDOLEAK. ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT THE TYPE II ENDOLEAK AND ANEURYSM GROWTH. THE ENDOLEAK WAS RESOLVED AND THE PATIENT TOLERATED THE PROCEDURE.

    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 030362301

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R