BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1843466 · Received September 20, 2010

    Report

    Report Number
    2017233-2010-00409
    Event Type
    Injury
    Date Received
    September 20, 2010
    Date of Event
    September 2, 2010
    Report Date
    September 20, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: 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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO REPAIR AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, THE PATIENT PRESENTED WITH PAIN IN HER RIGHT LEG. THE RIGHT EXTERNAL ILIAC WAS OCCLUDED NEAR THE ACCESS SITE OF THE INITIAL PROCEDURE. ON (B)(6), 2010, A REINTERVENTION WAS PERFORMED WHERE AN ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED, COVERING THE INTERNAL ILIAC ARTERY. FINAL ANGIOGRAPHY SHOWED FLOW IN THE LEG AND THE PATIENT TOLERATED THE PROCEDURE. PER THE PHYSICIAN, THERE WERE NO PROBLEMS WITH THE GORE EXCLUDER AAA ENDOPROSTHESES THAT WERE IMPLANTED IN THE PATIENT. THIS WAS A PROCEDURAL ISSUE.

    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 7580062

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R NORVASC| ALLOPURINOL| CHOLCHICINE| ADVAIR| LISINOPRIL| COMBIVENT| ASPIRIN| SYMBICORT