BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXCLUDER BIFURCATED ENDOPROSTHESIS

    MDR report key: 483225 · Received September 10, 2003

    Report

    Report Number
    2953161-2003-00046
    Event Type
    Injury
    Date Received
    September 10, 2003
    Date of Event
    August 11, 2003
    Report Date
    September 10, 2003
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ID, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    THE TRUNK-IPSILATERAL COMPONENT FOR THE EXCLUDER BIFURCATED ENDOPROSTHESIS (EBE) WAS SUCCESSFULLY DEPLOYED AND BALLOONED, FOLLOWED BY SUCCESSFUL PLACEMENT OF THE CONTRALATERAL LEG COMPONENT OF THE EBE. FINAL ANGIOGRAM REVEALED THAT THE TRUNK-IPSILATERAL COMPONENT HAD MIGRATED DISTALLY APPROXIMATELY 1.5CM FROM WHERE IT WAS DEPLOYED. THE LEFT SIDE OF THE PROXIMAL TRUNK WAS NOT IN THE ANEURYSMAL SAC, RESULTING IN A TYPE I ENDOLEAK. THE PHYSICIAN DID NOT FEEL CONFIDENT IN UTILIZING AN AORTIC EXTENDER IN THIS SITUATION AND THEREFORE CONVERT TO AN OPEN SURGICAL AAA REPAIR, WHICH WAS SUCCESSFULLY COMPLETED WITHOUT INCIDENT. PATIENT IS REPORTEDLY RECOVERING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCLUDER BIFURCATED ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W.L. GORE & ASSOCIATES,INC WLG325 0216102-01

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention