BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1180089 · Received September 29, 2008

    Report

    Report Number
    2953161-2008-00283
    Event Type
    Injury
    Date Received
    September 29, 2008
    Date of Event
    July 31, 2007
    Report Date
    September 26, 2008
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS: THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSIONS: ANEURYSM GROWTH IN THE ABSENCE OF ENDOLEAK HAS BEEN DEFINED AS ENDOTENSION. ONE HYPOTHESIS FOR THE SOURCE OF ENDOTENSION IS THE TRANSMURAL MOVEMENT OF SEROUS FLUID ACROSS THE MATERIAL USED TO FABRICATE DEVICES USED TO TREAT THE AORTIC ABDOMINAL ANEURYSM. IN RESPONSE TO THIS ISSUE, GORE ELECTED TO PROVIDE A DESIGN ENHANCEMENT TO THE ORIGINAL GORE EXCLUDER BIFURCATED ENDOPROSTHESIS. PLEASE REFER TO PMA SUPPLEMENT.

    Description of Event or Problem · 1

    IN 2003, THIS PATIENT PRESENTED WITH A 5 CM ABDOMINAL AORTIC ANEURYSM AND WAS IMPLANTED WITH GORE BIFURCATED ENDOPROSTHESES. IN 2007, THE PATIENT UNDERWENT A REINTERVENTION AND WAS IMPLANTED WITH A GORE CONTRALATERAL LEG COMPONENT TO TREAT A TYPE I ENDOLEAK AND A 3CM ANEURYSM IN THE LCI ARTERY. THE PATIENT WAS ALSO TREATED FOR 95% STENOSIS IN THE PROXIMAL LEFT RENAL ARTERY WITH A 6MM X 1.7CM EXPRESS STENT. POST-PROCEDURE ARTERIOGRAM SHOWED NO FURTHER STENOSIS OR ENDOLEAK AND THE ANEURYSM IN THE LCI ARTERY WAS COMPLETELY SEALED. AT AN UNKNOWN DATE, A FOLLOW-UP CT REVEALED THE ANEURYSM WAS STILL GROWING DUE TO ENDOTENSION FROM ORIGINAL IMPLANTED GRAFTS. IN 2008, THE PATIENT UNDERWENT AN ADDITIONAL REINTERVENTION AND THE EXISTING GRAFTS WERE RELINED WITH THREE ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESES. THE PATIENT IS REPORTED TO BE STABLE AT THIS TIME WITH NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS NONE MIH W. L. GORE & ASSOCIATES WLG325 022402504

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention