BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 757436 · Received August 31, 2006

    Report

    Report Number
    2953161-2006-00079
    Event Type
    Injury
    Date Received
    August 31, 2006
    Date of Event
    March 7, 2006
    Report Date
    August 30, 2006
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE REMAINS IMPLANTED. A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. NOTE: THIS EVENT WAS ORIGINALLY REPORTED UNDER MEDWATCH 2017233-2006-00064 ON 04/03/2006. INVESTIGATION REVEALED THE DEVICE ASSOCIATED WITH THIS EVENT WAS MANUFACTURED AT MANUFACTURING SITE #2953161 AND NOT MANUFACTURING SITE #2017233, THEREFORE, MEDWATCH 2953161-2006-00079 HAS BEEN CREATED TO CAPTURE THE CORRECT MANUFACTURING SITE.

    Description of Event or Problem · 1

    FOLLOWING SUCCESSFUL DEPLOYMENT OF A TRUNK-IPSILATERAL DEVICE, IT WAS DETERMINED THAT THE HYPOGASTRIC ARTERY WAS UNINTENTIONALLY COVERED. THE PHYSICIAN SUCCESSFULLY DEPLOYED THE CONTRALATERAL DEVICE. THE PHYSICIAN STATED THERE WAS NO APPARENT CLINICAL SEQUELA ASSOCIATED WITH LEAVING THE HYPOGASTRIC ARTERY COVERED, BUT WILL CONTINUE TO MONITOR THE PATIENT. THE PATIENT'S CONDITION WAS STABLE FOLLOWING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS ENDOVASCULAR GRAFT SYSTEM MIH W. L. GORE & ASSOCIATES, INC. WLG325 03738823

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other