BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2202357 · Received August 4, 2011

    Report

    Report Number
    2953161-2011-00175
    Event Type
    Injury
    Date Received
    August 4, 2011
    Date of Event
    July 12, 2011
    Report Date
    August 4, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THIS PT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT THE PT'S ANATOMY WAS NOT WITHIN IFU DUE TO A TORTUOUS PROXIMAL AORTIC NECK; HOWEVER, GOOD WALL APPOSITION OF THE TRUNK WAS REPORTEDLY NOTED ON FINAL ANGIOGRAPHY. ON (B)(6) 2011, F/U IMAGING IDENTIFIED A PROXIMAL TYPE I ENDOLEAK, WITH A 4 CM DISTAL MIGRATION OF THE TRUNK REPORTEDLY DUE TO THE PT'S TORTUOUS ANATOMY. IT WAS REPORTED THERE WAS NO EVIDENCE OF ANEURYSM ENLARGEMENT. ON (B)(6) 2011, THE PT WAS TAKEN TO THE OPERATING ROOM, WHERE ANGIOGRAPHY REVEALED THAT THE PROXIMAL END OF THE GRAFT WAS SITTING IN THE ANEURYSM SAC WITH NO PROXIMAL SEAL OR WALL APPOSITION IN THE SEAL ZONE. FOUR AORTIC EXTENDER COMPONENTS WERE IMPLANTED FOR PROXIMAL EXTENSION. COMPLETION ANGIOGRAPHY SHOWED ANEURYSM EXCLUSION AND FILLING OF BOTH RENAL ARTERIES, AND THE PT 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. WLG425 05947090

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Hospitalization| R DIGOXIN| LASIX| CARDIZEM| DIOVAN| COUMADIN