BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1780869 · Received July 29, 2010

    Report

    Report Number
    2953161-2010-00143
    Event Type
    Injury
    Date Received
    July 29, 2010
    Date of Event
    July 19, 2010
    Report Date
    July 29, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MFG PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECS. PLEASE NOTE AN ADDITIONAL DEVICE IMPLANTED AND RELATED TO THIS EVENT: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PT WAS IMPLANTED WITH FOUR GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, A PERSISTENT PROXIMAL TYPE I ENDOLEAK WAS NOTED AND AN AORTIC EXTENDER COMPONENT WAS IMPLANTED TO TREAT THE ENDOLEAK. THE ENDOLEAK WAS NOT RESOLVED AND THE PHYSICIAN HAS DECIDED TO TAKE A WAIT AND WATCH APPROACH. WHILE BALLOONING THE DISTAL PORTION OF THE ILIAC EXTENDER COMPONENT, THE PHYSICIAN INADVERTENTLY RUPTURED THE COMMON ILIAC ARTERY. THE RUPTURE WAS TREATED WITH AN ATRIUM ICAST STENT. THE RUPTURE WAS RESOLVED AND THE PT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG325 7770047

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| R