BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2474555 · Received February 27, 2012

    Report

    Report Number
    2953161-2012-00045
    Event Type
    Injury
    Date Received
    February 27, 2012
    Date of Event
    January 30, 2012
    Report Date
    January 30, 2012
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULT - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. CONCLUSION - THE ROOT CAUSE OF THE PXA COVERING THE RENAL ARTERY CANNOT BE DETERMINED WITH THE AVAILABLE INFORMATION.

    Description of Event or Problem · 1

    ON (B)(6), 2012, THIS PATIENT UNDERWENT A PROCEDURE USING GORE EXCLUDER AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. AFTER DEPLOYMENT OF A TRUNK-IPSILATERAL LEG COMPONENT, THE DEVICE MOVED 2 CM DISTALLY. THE PHYSICIAN ELECTED TO EXTEND PROXIMALLY WITH TWO AORTIC EXTENDER COMPONENTS; HOWEVER, THE SECOND AORTIC EXTENDER COMPONENT COVERED THE RIGHT RENAL ARTERY. THE PHYSICIAN ATTEMPTED TO PULL DOWN THE PXA, BUT THIS WAS NOT SUCCESSFUL. AFTER ATTEMPTING TO GAIN ACCESS INTO THE RIGHT RENAL ARTERY, THE PHYSICIAN ELECTED TO CONCLUDE THE PROCEDURE. A FEW DAYS POST-OPERATIVELY, IT WAS REPORTED THE PATIENT'S RENAL FUNCTION WAS IN THE NORMAL RANGE; HOWEVER, IMAGING SHOWED PARTIAL OCCLUSION OF THE RIGHT RENAL ARTERY. NO FURTHER ADVERSE EVENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES WLG425 9374943

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R