BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 7136857 · Received December 20, 2017

    Report

    Report Number
    2017233-2017-00669
    Event Type
    Injury
    Date Received
    December 20, 2017
    Date of Event
    January 1, 2012
    Report Date
    January 19, 2018
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    USERS ARE MADE AWARE OF THE RISKS ASSOCIATED WITH TYPE II ENDOLEAKS IN THE IFU AND ARE INSTRUCTED TO CONSIDER THE RISKS AND BENEFITS DISCUSSED IN THE IFU FOR EACH PATIENT BEFORE USING THE DEVICES.

    Additional Manufacturer Narrative · 1

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE® EXCLUDER® AAA ENDOPROSTHESES (PXT261414/8956838, PXC161000/9081813, AND PXC181200/8738193). ON AN UNKNOWN DATE, 2012, TYPE II ENDOLEAK WAS REPORTED. COILING FOR TYPE II ENDOLEAK WAS PERFORMED. ON (B)(6) 2017, GORE® EXCLUDER® AAA ENDOPROSTHESES WERE REPLACED BY ARTIFICIAL BLOOD VESSEL SINCE THE SHAPE OF ANEURYSM AND VESSEL WERE NOT GOOD FOR BLOOD FLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912279 GORE® EXCLUDER® AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 8956838

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Hospitalization| R