BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1231646 · Received November 14, 2008

    Report

    Report Number
    2017233-2008-00871
    Event Type
    Injury
    Date Received
    November 14, 2008
    Date of Event
    October 22, 2008
    Report Date
    November 13, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE VERIFIED THAT THE LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    THE PATIENT WAS TREATED FOR AN AAA ANEURYSM IN 2008. TWO HOURS, POST-PROCEDURE, THE PHYSICIAN ASSESSED THE PATIENT'S LEFT FOOT TO BE COOL. ON THE SAME DAY, THE PATIENT RETURNED TO THE OR FOR A CUT DOWN OF THE LEFT COMMON FEMORAL ARTERY, THE SUPERFICIAL FEMORAL ARTERY AND THE DEEP FEMORAL ARTERY. A VESSEL FLAP WAS DISCOVERED COVERING THE LUMEN AND CREATING VESSEL OCCLUSION. AN ENDARTERECTOMY WAS PERFORMED AND THE VESSEL OCCLUSION WAS REPAIRED. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W.L. GORE & ASSOCIATES,INC WLG325 05925871

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR