BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1822786 · Received August 30, 2010

    Report

    Report Number
    2953161-2010-00158
    Event Type
    Injury
    Date Received
    August 30, 2010
    Date of Event
    July 1, 2009
    Report Date
    August 27, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK WILL BE CONDUCTED. IMAGES OF THIS EVENT, HAVE BEEN SENT TO GORE AND ARE IN THE PROCESS OF BEING EVALUATED.

    Description of Event or Problem · 1

    ON (B)(6) 2004, THIS PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER BIFURCATED ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. PRIOR TO THIS PROCEDURE, THE PATIENT UNDERWENT A NEPHRECTOMY DUE TO RENAL CELL CARCINOMA. ON (B)(6) 2009, THE PATIENT WAS TREATED FOR A TYPE II ENDOLEAK WITH TRANSLUMBAR PUNCTURE OF THE ANEURYSM SAC THROUGH THE INFERIOR MESENTERIC ARTERY. ON AN UNKNOWN DATE, THE PATIENT WAS IDENTIFIED WITH ANEURYSM ENLARGEMENT. ON (B)(6) 2010, THE PATIENT WAS ADDITIONALLY TREATED FOR A TYPE II ENDOLEAK WITH COIL EMBOLIZATION. THE PATIENT TOLERATED THE PROCEDURE WITHOUT ANY COMPLICATIONS. AT THIS TIME, THE PARTIAL RUPTURE OF THE IPSILATERAL LEG OF THE TRUNK-IPSILATERAL LEG COMPONENT WAS NOTICED. ACCORDING TO THE PHYSICIAN, THE RUPTURE IS NOT THE CAUSE OF THE ANEURYSM ENLARGEMENT. THE PHYSICIAN IS PLANNING TO COVER THIS SITE WITH ANOTHER DEVICE. IMAGES OF THIS EVENT, HAVE BEEN SENT TO GORE AND ARE IN THE PROCESS OF BEING EVALUATED.

    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 041051516A

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R PC-14-12-00/(B)(4)