BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1180048 · Received September 26, 2008

    Report

    Report Number
    2953161-2008-00280
    Event Type
    Injury
    Date Received
    September 26, 2008
    Date of Event
    August 26, 2008
    Report Date
    September 25, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MFG RECORDS VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: DEVICE USED OUTSIDE OF INSTRUCTIONS FOR USE (IFU). ACCORDING TO THE IFU, AORTIC NECK ANGULATION SHOULD BE LESS THAN 60 DEGREE. ANOTHER DEVICE CAUSED FAILURE. THE 25 MM MAXI LD BALLOON WAS USED IN A VESSEL MEASURING 16-21 MM.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN INFRARENAL ABDOMINAL AORTIC ANEURYSM. DURING THE PROCEDURE, THERE WAS A PERSISTENT PROXIMAL TYPE 1 ENDOLEAK OF THE TRUNK-IPSILATERAL LEG COMPONENT. AN AORTIC EXTENDER WAS PLACED TO ADDRESS THE ENDOLEAK. AFTER SEATING WITH A 25 MM MAXI LD BALLOON, THE AORTA RUPTURED. THE PHYSICIAN CONVERTED TO OPEN SURGERY TO EXPLANT THE ENDOPROTHESES AND COVER THE RUPTURE WITH ANOTHER BIFURCATED VASCULAR GRAFT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 04919045

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Life Threatening| R