BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2973961 · Received February 14, 2013

    Report

    Report Number
    2017233-2013-00071
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 18, 2013
    Report Date
    January 11, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2004, THE PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM WITH GORE EXCLUDER AAA ENDOPROSTHESES. ON (B)(6) 2013, A DISTAL TYPE I ENDOLEAK WAS IDENTIFIED ON THE TRUNK, WHICH APPEARED TO BE RELATED TO EXPANSION OF THE LEFT COMMON ILIAC ARTERY. FAINT CONTRAST WAS APPARENT IN THE PROXIMAL LEFT COMMON ILIAC, BUT NO CONTRAST WAS VISIBLE IN THE ANEURYSM SAC. THE PHYSICIAN DID NOT REPORT ANY ANEURYSM ENLARGEMENT. ON (B)(6) 2013, A CONTRALATERAL LEG COMPONENT WAS IMPLANTED TO EXTEND DISTALLY INTO THE LEFT EXTERNAL ILIAC ARTERY, INTENTIONALLY COVERING THE HYPOGASTRIC ARTERY. IT WAS ALSO REPORTED THE PHYSICIAN ELECTED TO EXTEND PROXIMALLY WITH TWO AORTIC EXTENDER COMPONENTS TO PREVENT THE DEVELOPMENT OF A PROXIMAL ENDOLEAK. FINAL ANGIOGRAPHY SHOWED NO EVIDENCE OF ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66242 GORE EXCLUDER AAA ENDOPROSTHESIS MIH W.L. GORE & ASSOCIATES 03101656

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Hospitalization| R VYTORIN| LOVASTATIN