BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1812180 · Received August 19, 2010

    Report

    Report Number
    2953161-2010-00151
    Event Type
    Injury
    Date Received
    August 19, 2010
    Date of Event
    July 23, 2010
    Report Date
    August 19, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 DEVICES IMPLANTED AND INVOLVED IN THIS EVENT. (B)(4)

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. IN (B)(6) 2010, THE PATIENT DEVELOPED ABDOMINAL AND BACK PAIN. IT WAS REPORTED THE PATIENT WAS BACTEREMIC AND HAD A STAPH INFECTION. ON (B)(6) 2010, A CT FOUND A SWAY INFECTION (PUS AND FLUID) AROUND THE GRAFT, BUT THE PHYSICIAN REPORTED THERE WERE NO ENDOLEAKS AND THE GRAFT WAS WORKING PERFECTLY. ON (B)(6) 2010, ALL THREE GORE EXCLUDER AAA ENDOPROSTHESES WERE EXPLANTED DUE TO A (B)(6) INFECTION AROUND THE ENDOGRAFTS. ACCORDING TO THE PHYSICIAN, THE ORIGINAL SOURCE OF THE INFECTION IS UNKNOWN. THE PHYSICIAN ALSO REMOVED THROMBUS FROM THE SAC, THEN PERFORMED AN ENDARTERECTOMY OF THE ENTIRE ANEURYSM SAC TO REMOVE ANY OF THE PREVIOUSLY INFECTED MATERIAL. THE PATIENT TOLERATED THE PROCEDURE.

    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, INC. WLG325 05684979

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R ACETAMINOPHEN| ZEMPLAR| DIOVAN| COREG| ZOFRAN| XANAX| MULTAQ| FERRIC GLUCONATE| ZOCOR| ARANESP| ASPIRIN| RENAGEL| DIALYVITE| PERCOCET| PREDNISONE| HYDROCODONE