BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1201788 · Received October 15, 2008

    Report

    Report Number
    2953161-2008-00302
    Event Type
    Injury
    Date Received
    October 15, 2008
    Date of Event
    August 6, 2008
    Report Date
    October 14, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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. OTHER DEVICE IMPLANTED IN THE PATIENT AND RELATED TO THIS EVENT INCLUDES GORE EXCLUDER AAA ENDOPROSTHESIS PXC141200.

    Description of Event or Problem · 1

    IN 2008, THE PATIENT WAS IMPLANTED WITH A GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ON APPROX FIVE WEEKS LATER, A RADIOLOGY REPORT INDICATED A TYPE I AND TYPE III ENDOLEAK WITH NO CHANGE IN ANEURYSM SAC SIZE. ACCORDING TO AN EVALUATION OF THE IMAGES BY GORE, THERE APPEARS TO BE A TYPE II ENDOLEAK COMING FROM THE LUMBAR ARTERIES AND THE INFERIOR MESENTERIC ARTERY COMBINED WITH A DISTAL TYPE I ENDOLEAK COMING FROM BOTH THE TRUNK-IPSILATERAL AND CONTRALATERAL LIMBS WHICH IS DUE TO NOT ENOUGH WALL APPOSITION WITHIN BOTH COMMON ILIAC ARTERIES. IT IS ALSO NOTED THAT THERE WAS 16.8MM AND 12.8MM OF DISTANCE BETWEEN THE DISTAL ENDS OF THE GORE EXCLUDER AAA ENDOPROSTHESES AND THE RIGHT AND LEFT COMMON ILIAC BIFURCATIONS, RESPECTIVELY. THE GORE IMAGING EVALUATION DID NOT MENTION THE TYPE III ENDOLEAK NOTED IN THE RADIOLOGY REPORT. ON TWO MONTHS LATER, THE PATIENT UNDERWENT A RE-INTERVENTION TO INCLUDE TWO GORE EXCLUDER AAA ENDOPROSTHESES ILIAC EXTENDERS WERE IMPLANTED IN BOTH THE RIGHT AND LEFT ILIACS. THE PROCEDURE WAS SUCCESSFUL AND NO EVIDENCE OF AN ENDOLEAK WAS NOTICED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 05688787

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Other