BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1071422 · Received July 8, 2008

    Report

    Report Number
    2017233-2008-00368
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 10, 2008
    Report Date
    July 7, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED.

    Description of Event or Problem · 1

    AS REPORTED IN 2008, THIS PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN RUPTURED ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN CHOSE NOT TO BALLOON THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG COMPONENT DUE TO CALCIUM. THE PROCEDURE WENT WELL WITH NO APPARENT ENDOLEAKS. THREE DAYS LATER, A CT SCAN REVEALED A PROXIMAL TYPE I ENDOLEAK. THE PATIENT UNDERWENT A REINTERVENTION IN WHICH BALLOON ANGIOPLASTY WAS PERFORMED ON THE PROXIMAL PORTION OF THE TRUNK-IPSILATERAL LEG COMPONENT. THE NEXT DAY, THE PHYSICIAN REPORTED THAT THERE IS NO EVIDENCE OF A TYPE I ENDOLEAK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES, INC. WLG325 05843656

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention