BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3881215 · Received February 12, 2014

    Report

    Report Number
    2953161-2014-00018
    Event Type
    Malfunction
    Date Received
    February 12, 2014
    Date of Event
    January 16, 2014
    Report Date
    January 16, 2014
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON AN UNKNOWN DATE IN 2004, THIS PATIENT WAS IMPLANTED WITH AN ANCURE STENT GRAFT TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IMAGES FROM AN UNKNOWN DATE, REVEALED THE PATIENT HAD DEVELOPED A DISTAL TYPE 1 ENDOLEAK IN THE RIGHT COMMON ILIAC ARTERY AND A TYPE 111 ENDOLEAK (TEAR IN GRAFT MATERIAL) IN THE LEFT COMMON ILIAC ARTERY. THE PHYSICIAN CHOSE TO RELINE BOTH GRAFTS WITH GORE EXCLUDER AAA ILIAC EXTENDER COMPONENTS. THE PATIENT HAD VERY TORTUOUS ANATOMY IN THE COMMON ILIAC ARTERIES. IT WAS REPORTED WHILE THE PHYSICIAN WAS ADVANCING THE PXL1611207 ON THE RIGHT SIDE HE FELT RESISTANCE, HE BELIEVED THE RESISTANCE WAS DUE TO DOING THROUGH AN EXISTING ANCURE GRAFT AND THE TORTUOUS ANATOMY. HE CONTINUED ADVANCING AND DEPLOYED THE ILIAC EXTENDER COMPONENT IN THE DESIRED LOCATION. UPON RETRACTING THE DELIVERY CATHETER THE DISTAL OLIVE HAD BECOME BROKE OFF FROM THE DELIVERY CATHETER AND BECOME SEPARATED. THE DISTAL SEPARATED END WAS CAUGHT ON THE 12FR DRYSEAL SHEATH. THE PHYSICIAN RETRACTED THE DELIVERY CATHETER AND THEN REMOVED THE BROKEN PIECE OF CATHETER WITH THE DRYSEAL SHEATH THAT WAS REMOVED FROM THE PATIENT. THE PROCEDURE CONCLUDED WITH NO FURTHER EVENT. THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92261 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES, INC. NA 10420897

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR