BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2211277 · Received August 3, 2011

    Report

    Report Number
    2953161-2011-00172
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    December 29, 2009
    Report Date
    August 2, 2011
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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. (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES FOR TREATMENT OF AN INFRARENAL AORTIC ANEURYSM. ON (B)(6) 2008, CT REVEALED A TYPE II ENDOLEAK. ON (B)(6) 2009, THE PT UNDERWENT AN INTERVENTION TO COIL THE TYPE II ENDOLEAK. THERE WERE FOUR LUMBAR ARTERIES AND THE IMA FILLING THE SAC. ONYX GLUE WAS INJECTED INTO THE SAC. COILS WERE ALSO PLACED. POST OPERATIVE CT SHOWED CONTINUED SAC EXPANSION. ON (B)(6) 2011, THE PT UNDERWENT OPEN CONVERSION. THE PROXIMAL 7 CM'S OF THE GORE EXCLUDER AAA ENDOPROSTHESIS WAS REMOVED BY SLIDING THE CONTRA LIMB OUT OF THE GATE AND CUTTING THE IPSILATERAL LIMB AT THE LEVEL OF THE CONTRALATERAL GATE. THE PHYSICIAN TIED OFF THE LIMBS OF THE ENDOGRAFT THAT REMAINED AND PERFORMED AN AORTOBI ILIAC BYPASS GRAFT WITH A DACRON BIFURCATED GRAFT SEWING THE DISTAL LIMBS OF THE DACRON GRAFT DISTAL TO THE LIMBS OF THE PREVIOUSLY IMPLANTED GORE EXCLUDER AAA ENDOPROSTHESIS DEVICE. 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 WLG325 05209201

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R PREDNISONE| SIMVASTATIN| ASA| IRON