BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4232013 · Received November 6, 2014

    Report

    Report Number
    2953161-2014-00128
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    June 26, 2009
    Report Date
    October 24, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESES. COIL EMBOLIZATION OF BOTH THE RIGHT AND LEFT HYPOGASTRIC ARTERIES WERE PERFORMED DURING THE PROCEDURE. THE PROCEDURE CONCLUDED WITHOUT ANY INCIDENT. ON (B)(6) 2009, AT THE ONE-MONTH FOLLOW-UP, THE ANEURYSM MEASURED 60 MM X 48 MM. NO ENDOLEAK WAS SEEN. ON (B)(6) 2009, AT THE SIX-MONTH FOLLOW-UP, THE ANEURYSM DIAMETER HAD INCREASED TO 65 MM X 50 MM. NO ENDOLEAK WAS SEEN. A WAIT-AND-WATCH APPROACH WAS TAKEN. ON (B)(6) 2009, AT THE ONE-YEAR FOLLOW-UP, THE ANEURYSM HAD INCREASED TO 67 MM X 52 MM. AGAIN, NO ENDOLEAK WAS SEEN. THE PHYSICIAN CONTINUED THE WAIT-AND-WATCH APPROACH. NO FURTHER INFORMATION HAS BEEN REPORTED TO GORE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714691 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 06333692

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Other IMPLANTED 12/8/08: PXC121400, (2) PXL161007