BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2973957 · Received February 14, 2013

    Report

    Report Number
    2017233-2013-00074
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    December 4, 2012
    Report Date
    January 18, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: PER THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH TWO GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON (B)(6) 2012, CT SCAN DETECTED A PROXIMAL TYPE I ENDOLEAK. IT IS UNKNOWN WHETHER ANEURYSM ENLARGEMENT WAS PRESENT. ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH AN AORTIC EXTENDER COMPONENT TO TREAT THE PROXIMAL TYPE I ENDOLEAK. THE ENDOLEAK WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66162 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 9732477

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Hospitalization| R METFORMIN| WARFARIN| ATENOLOL| ASPIRIN