BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2221253 · Received August 17, 2011

    Report

    Report Number
    2017233-2011-00426
    Event Type
    Injury
    Date Received
    August 17, 2011
    Date of Event
    July 21, 2011
    Report Date
    August 16, 2011
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS HAS BEEN CONDUCTED. THE MFG RECORDS REVIEW VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6), 2011, THE PT UNDERWENT A PROCEDURE TO TREAT AN ENDOLEAK. THE CONTRALATERAL LEG WAS EXTENDED DISTALLY, RESOLVING THE ENDOLEAK.

    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 05302131

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R