BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2091470 · Received May 5, 2011

    Report

    Report Number
    2953161-2011-00109
    Event Type
    Injury
    Date Received
    May 5, 2011
    Date of Event
    December 22, 2009
    Report Date
    May 5, 2011
    Manufacturer
    W. L. GORE AND ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICE IMPLANTED AND INVOLVED IN THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6), 2005, THIS PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2009, FOLLOW-UP IMAGING IDENTIFIED AN INFECTED PARARENAL ABDOMINAL AORTIC ANEURYSM, INFECTED AORTIC STENT GRAFT, AND A TYPE I ENDOLEAK. ON (B)(6), 2009, THE GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED DUE TO THE INFECTION. THE PATIENT TOLERATED THE PROCEDURE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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 AND ASSOCIATES, INC. WLG325 042190211

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R ZOCOR| CEFTRIAXONE| VANCOMYCIN| PATIENT MEDICATIONS INCLUDE: LOPRESSOR