BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1923564 · Received December 10, 2010

    Report

    Report Number
    2017233-2010-00548
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    December 18, 2009
    Report Date
    December 9, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: METHOD: A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: AS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, COMPLICATIONS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO, ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6), 2007, THE PT WAS TREATED FOR AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. ON (B)(6), 2009, A REINTERVENTION OCCURRED. A GORE EXCLUDER AAA ENDOPROSTHESIS WAS PLACED TO TREAT A PROXIMAL TYPE - 1 ENDOLEAK. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM ENDOVASCULAR GRAFT AORTIC ANUERYSM TERATMENT MIH W.L. GORE & ASSOCIATES WLG325 0460

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ALLOPURINOL| FUROSEMIDE| BENAZDPRIL| MULTI-VITAMINS| POTASSIUM| ANTENOLOL