BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1881101 · Received October 20, 2010

    Report

    Report Number
    2953161-2010-00189
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    October 6, 2010
    Report Date
    October 19, 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 MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, TYPE II ENDOLEAKS ARE A KNOWN RISK FACTOR FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSMS. PLEASE NOTE ADDITIONAL DEVICES IMPLANTED: PXC141400/(B)(4) AND PXL161407/(B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS TREATED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES, FOR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2010 AND (B)(6) 2010, CT SHOWED A PROXIMAL TYPE 1 ENDOLEAK. ON (B)(6) 2010, AN INTERVENTION OCCURRED WHERE AN AORTIC EXTENDER COMPONENT WAS PLACED IN THE PROXIMAL END OF THE TRUNK-IPSILATERAL LEG COMPONENT. WHEN IMAGING WAS READ DURING THE PROCEDURE, IT WAS DETERMINED THAT THE ENDOLEAK WAS ACTUALLY A TYPE II ENDOLEAK. THE PT TOLERATED THE PROCEDURE. NO ANEURYSM GROWTH WAS REPORTED. THE PHYSICIAN WILL CONTINUE TO MONITOR 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 WLG325 7167257

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R