BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1000180 · Received February 18, 2008

    Report

    Report Number
    2017233-2008-00073
    Event Type
    Injury
    Date Received
    February 18, 2008
    Date of Event
    January 23, 2008
    Report Date
    February 18, 2008
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PLEASE NOTE: ATTACHED LIST OF ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXT281414/LOT#03582263, PXC181200/LOT#03803299.

    Description of Event or Problem · 1

    IN 2005, A GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED TO REPAIR AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. THE PHYSICIAN CHOSE NOT TO COMPLETELY EXCLUDE A PRE-EXISTING, PRE-ANEURYSMAL SEGMENT OF THE PATIENT'S RIGHT COMMON ILIAC ARTERY. FOLLOW-UP IMAGES REVEALED THAT THE PRE-ANEURYSMAL SEGMENT OF THE RIGHT COMMON ILIAC ARTERY HAD INCREASED IN DIAMETER. IN 2008, THE PATIENT'S RIGHT HYPOGASTRIC ARTERY WAS COILED AND A GORE TAG THORACIC ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT WAS IMPLANTED. IT WAS REPORTED THAT THE PATIENT TOLERATED 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 03777693

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention