BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1841116 · Received September 17, 2010

    Report

    Report Number
    2017233-2010-00405
    Event Type
    Injury
    Date Received
    September 17, 2010
    Date of Event
    March 2, 2010
    Report Date
    September 16, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 SPECS. ADDITIONAL GORE DEVICES RELATED TO THIS EVENT: (B)(4), (B)(4). 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), 2009, THE PT WAS IMPLANTED WITH FIVE GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6), 2010, A REINTERVENTION OCCURRED TO TREAT AN ENLARGING ANEURYSM AND A LARGE TYPE-3 ENDOLEAK BETWEEN TWO STENT GRAFT SEGMENTS IN THE RIGHT COMMON ILIAC ARTERY. THE PT WAS IMPLANTED WITH AN ADDITIONAL GORE EXCLUDER AAA CONTRALATERAL LEG COMPONENT. THE TYPE-3 ENDOLEAK WAS RESOLVED. FINAL AORTOGRAPHY SHOWED A SMALL TYPE-2 ENDOLEAK FROM A COLLATERAL VESSEL OF THE RIGHT HYPOGASTRIC ARTERY. THE PT WAS STABLE UPON COMPLETION. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED. THE PHYSICIAN WILL CONTINUE TO MONITOR THE PT.

    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 06747883

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R ASPIRIN| HYDROCHLOROTHIAZIDE (HCTZ)| AMLODIPINE