BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1689812 · Received May 12, 2010

    Report

    Report Number
    2953161-2010-00080
    Event Type
    Injury
    Date Received
    May 12, 2010
    Date of Event
    April 28, 2010
    Report Date
    May 12, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DEVICES IMPLANTED AND RELATED TO THIS EVENT: PXA280300/7240285.

    Description of Event or Problem · 1

    ON (B) (6) 2010, THE PT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B) (6) 2010, THE PT HAD A THREE MONTH FOLLOW-UP COMPUTED TOMOGRAPHY THAT REVEALED A TYPE III ENDOLEAK BETWEEN THE TRUNK-IPSILATERAL LEG COMPONENT AND AORTIC EXTENDER COMPONENT. THE SAME DAY, A REINTERVENTION WAS PERFORMED TO TREAT THE TYPE III ENDOLEAK. AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO COVER THE OVERLAPPED AREA OF TWO ORIGINALLY IMPLANTED DEVICES. THE ENDOLEAK WAS RESOLVED AND THE PT 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 7085977

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R