BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 5835893 · Received August 1, 2016

    Report

    Report Number
    2017233-2016-00671
    Event Type
    Injury
    Date Received
    August 1, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    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

    THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. PXC161000/9081813 = UDI: (B)(4).

    Description of Event or Problem · 1

    ON (B)(6) 2011, THE PATIENT UNDERWENT ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDER AAA ENDOPROSTHESES. ON AN UNKNOWN DATE, FOLLOW-UP IMAGINGS IDENTIFIED AN ENLARGING RIGHT COMMON ILIAC ARTERY (RCIA) AND THE ANEURYSM ENLARGEMENT OF UNKNOWN AMOUNT. ON (B)(6) 2016, AN INTERVENTION WAS PERFORMED TO TREAT THE ENLARGING RCIA AND ANEURYSM. IT WAS REPORTED THAT NO EVIDENCE OF ENDOLEAK WAS IDENTIFIED DURING AN ANGIOGRAPHY PRIOR TO THE DEVICE IMPLANT. A CONTRALATERAL LEG COMPONENT WAS IMPLANTED FOR DISTAL EXTENSION OF THE PREVIOUSLY IMPLANTED CONTRALATERAL LEG COMPONENT (PXC161000/9081813) ON THE RIGHT SIDE AND LANDED INTO THE RIGHT EXTERNAL ILIAC ARTERY. ADDITIONALLY, THE RIGHT INTERNAL ILIAC ARTERY WAS COIL EMBOLIZED AS IT WAS INTENTIONALLY COVERED BY THE ADDITIONAL DEVICE. THE ILIAC AND ANEURYSM ENLARGEMENT WAS SUCCESSFULLY EXCLUDED AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    489096 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 9081813

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Hospitalization| R