BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2122978 · Received June 9, 2011

    Report

    Report Number
    2953161-2011-00134
    Event Type
    Injury
    Date Received
    June 9, 2011
    Date of Event
    May 11, 2011
    Report Date
    June 9, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAVE NOT BEEN EVALUATED IN PATIENT POPULATIONS WITH LEAKING (PENDING RUPTURE OR RUPTURED) ANEURYSMS.

    Description of Event or Problem · 1

    ON (B)(6), 2011, THE PATIENT WAS TREATED EMERGENTLY FOR A RUPTURING ABDOMINAL AORTIC ANEURYSM MEASURING ABOUT 9 CM, AND WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESIS. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE WELL. ON (B)(6), 2011, THE PATIENT EXPERIENCED A HOT BELLY AND WAS TREATED FOR SEPSIS. ANTIBIOTICS WERE ADMINISTERED AT THAT TIME. ON (B)(6), 2011, THE PATIENT WAS CONVERTED TO OPEN SURGICAL REPAIR TO TREAT AN ABDOMINAL INFECTION. THE INFECTED GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED. THE PATIENT WAS STABLE UPON COMPLETION. ON (B)(6), 2011, THE PATIENT WAS SEEN ON A FOLLOW-UP VISIT AND WAS DOING WELL.

    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 7408649

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| O| R (B)(4)| (B)(4)