BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3581588 · Received January 10, 2014

    Report

    Report Number
    2017233-2014-00010
    Event Type
    Injury
    Date Received
    January 10, 2014
    Date of Event
    January 9, 2014
    Report Date
    January 9, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES,INC
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT/SERIAL NUMBER IS UNKNOWN. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE COULD NOT BE CONDUCTED. FURTHER INFO WAS REQUESTED. ALSO WAS IMPLANTED PXC/UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH GORE EXCLUDER AAA ENDOPROSTHESES. IT WAS REPORTED THAT ANOTHER EXTENDER DEVICE (UNKNOWN) WAS IMPLANTED BEFORE THE INITIAL PROCEDURE. ON (B)(6) 2010, THE PATIENT HAD A REINTERVENTION TO TREAT A TYPE 1 ENDOLEAK ON THE RIGHT SIDE. ON (B)(6) 2013, IT WAS REPORTED THAT THE PATIENT EXPERIENCED A DISTAL TYPE 1 ENDOLEAK. ON (B)(6) 2014, THE PATIENT UNDERWENT AN ADDITIONAL PROCEDURE USING THE GORE EXCLUDER AAA ENDOPROSTHESIS TO TREAT A DISTAL TYPE 1 ENDOLEAK ON THE LEFT SIDE. THE HYPOGASTRIC ARTERY WAS COVERED. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. FURTHER INFO WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    17903 GORE EXCLUDER AAA ENDOPROSTHESIS MIH/SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES,INC

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Hospitalization| R