BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2001643 · Received February 18, 2011

    Report

    Report Number
    2017233-2011-00076
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    February 1, 2011
    Report Date
    February 17, 2011
    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

    METHOD - A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE MANUFACTURING RECORDS REVIEW VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2011, THE PATIENT UNDERWENT SURGERY FOR LIGATION OF THE IMA. THE PATIENT TOLERATED THE PROCEDURE, AND THE ENDOLEAK WAS RESOLVED.

    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 06406802

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Hospitalization| R PXC181400/#06058313| PXC201000/#06410366