BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1931806 · Received December 9, 2010

    Report

    Report Number
    2017233-2010-00545
    Event Type
    Malfunction
    Date Received
    December 9, 2010
    Date of Event
    November 15, 2010
    Report Date
    December 8, 2010
    Manufacturer
    W.L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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.

    Description of Event or Problem · 1

    ON (B)(6), 2010, THIS PT WAS UNDERGOING TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH A GORE EXCLUDER AAA ENDOPROSTHESIS. A TRUNK-IPSILATERAL LEG COMPONENT WAS ADVANCED FORM THE LEFT COMMON ILIAC ARTERY, WHICH HAD A 90 DEGREE TURN BEFORE LEADING INTO THE AORTA. IT WAS ALSO REPORTED THAT THE SHEATH WAS "TIGHT" AT THE AORTIC BIFURCATION. THE DEVICE SEEMED TO MEET SOME RESISTANCE AS IT WAS BEING ADVANCED INTO POSITION, SO THE PHYSICIAN PUSHED THE DEVICE TO MOVE PAST THE RESISTANCE IN THE SHEATH. WHEN THE DEVICE WAS IN POSITION AND THE DEPLOYMENT KNOB WAS PULLED, THE DEVICE DID NOT DEPLOY. IT WAS REPORTED THE DEPLOYMENT LINE BROKE HALFWAY THROUGH THE PULL. IT WAS REPORTED THAT WHEN THE DEVICE WAS REMOVED FROM THE PT, THE STRING THAT CONNECTS THE DEVICE TO THE CATHETER SEEMED TO BE CUT. THE PROCEDURE CONTINUED WITH ANOTHER TRUNK-IPSILATERAL LEG COMPONENT, AND THE PT TOLERATED THE PROCEDURE. THERE WAS NO ADVERSE EVENT TO THE PT. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    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, INC. WLG425 8148138

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR