BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2771914 · Received September 28, 2012

    Report

    Report Number
    2017233-2012-00661
    Event Type
    Injury
    Date Received
    September 28, 2012
    Date of Event
    September 5, 2012
    Report Date
    September 5, 2012
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: THE REVIE OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXC201000/04473427. PXC201400/04005526.

    Description of Event or Problem · 1

    ON (B)(6) 2006, THE PATIENT WAS IMPLANTED WITH THREE GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, A COMPUTED TOMOGRAPHY REVEALED A DISTAL TYPE I ENDOLEAK ON THE RIGHT SIDE AND A PROXIMAL TYPE I ENDOLEAK. NO ANEURYSM GROWTH WAS NOTED. ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH A MEDTRONIC ENDURANT STENT GRAFT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE PATIENT'S RIGHT INTERNAL ILIAC ARTERY WAS COILED EMBOLIZED AND TWO GORE EXCLUDER AAA ENDOPROSTHESIS WERE IMPLANTED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE PATIENT TOLERATED THE PROCEDURE.

    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 04588995

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R ASAPRIN| PURINOL| TOPORAL| LIPITOR