BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2071776 · Received April 20, 2011

    Report

    Report Number
    2953161-2011-00096
    Event Type
    Injury
    Date Received
    April 20, 2011
    Date of Event
    March 24, 2011
    Report Date
    April 20, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PT WAS IMPLANTED WITH SIX GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL COMMON ILIAC ARTERY ANEURYSMS. DURING THE PROCEDURE, THE RIGHT INTERNAL ILIAC ARTERY WAS EMBOLIZED USING AN AMPLATZER PLUG. A SNORKEL TECHNIQUE USING GORE VIABAHN DEVICES WAS PERFORMED TO STENT THE LEFT INTERNAL ILIAC ARTERY AND THE LEFT EXTERNAL ILIAC ARTERY. ON AN UNK DATE, A DISTAL TYPE I ENDOLEAK WAS FOUND FROM THE RIGHT COMMON ILIAC ARTERY GRAFT. ON (B)(6) 2011, THE PT WAS IMPLANTED WITH ONE GORE EXCLUDER AAA ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT TO TREAT A DISTAL TYPE I ENDOLEAK. 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 WLG425 8592770

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R 8452738/ (B)(4)| 8484869/ (B)(4)| 8212285/ (B)(4)| 8426904/ (B)(4)