BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1091844 · Received July 31, 2008

    Report

    Report Number
    2017233-2008-00421
    Event Type
    Injury
    Date Received
    July 31, 2008
    Date of Event
    July 7, 2008
    Report Date
    July 30, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK IS BEING CONDUCTED. THE PT WAS NOT AN IDEAL CANDIDATE FOR ENDOVASCULAR REPAIR DUE TO A SHORT PROXIMAL LANDING ZONE OUTSIDE THE RECOMMENDATIONS STATED IN THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE. HOWEVER, THE PT WAS CONSULTED AND CONSENTED TO THE PROCEDURE.

    Description of Event or Problem · 1

    IN 2007, THE PT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TRUNK IPSILATERAL LEG COMPONENT, CONTRALATERAL LEG COMPONENT AND ILIAC EXTENDER COMPONENT. UPON DEPLOYMENT OF THE TRUNK-IPSILATERAL LEG COMPONENT, THE DEVICE UNINTENTIONALLY COVERED THE LEFT INTERNAL ILIAC ARTERY. AFTER DEPLOYING THE CONTRALATERAL LEG COMPONENT, THE PHYSICIAN BALLOONED OUTSIDE OF THE DEVICE CAUSING A DISSECTION IN THE RIGHT COMMON ILIAC ARTERY; HOWEVER, THE DISSECTION WAS COVERED BY EXTENDING TO THE RIGHT INTERNAL ILIAC ARTERY WITH AN ILIAC EXTENDER COMPONENT. THE PT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES WLG325 05415510

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other