BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3001636 · Received March 8, 2013

    Report

    Report Number
    2017233-2013-00123
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    August 6, 2012
    Report Date
    February 26, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. ALSO WAS IMPLANTED (B)(4). THE DATE OF THE REINTERVENTION IS UNKNOWN, THE DATE OF HOSPITALIZATION (B)(6) 2012 WILL BE USED AS A DATE OF EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE PRE-IMPLANTED COMPUTED TOMOGRAPHY ANGIOGRAPHY SHOWED THE ANEURYSM SIZE WAS 68MM. ON (B)(6) 2011, A FOLLOW-UP EXAM SHOWED THE ANEURYSM SIZE WAS 73MM. ON (B)(6) 2012, AN ULTRASOUND SHOWED THE ANEURYSM SIZE WAS 64MM. ON (B)(6) 2012, THE PATIENT WAS HOSPITALIZED DUE TO AN ENDOLEAK. ON AN UNKNOWN DATE IN (B)(6)2012, THE PATIENT UNDERWENT A REINTERVENTION AND A 28MM AORTIC CUFF WAS IMPLANTED. ALSO, THE PATIENT UNDERWENT AN EMBOLIZATION PROCEDURE USING ONYX GLUE TO FIX AN ENDOLEAK FROM ILIO LUMBAR ARTERY. BOTH TYPE I AND TYPE II ENDOLEAKS WERE FIXED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    99675 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9222381

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R