BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 1921066 · Received December 6, 2010

    Report

    Report Number
    2953161-2010-00224
    Event Type
    Injury
    Date Received
    December 6, 2010
    Date of Event
    November 4, 2009
    Report Date
    December 6, 2010
    Manufacturer
    W. L. GORE & ASSOCIATES, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD - A REVIEW OF THE MANUFACTURING PAPERWORK HAS BEEN CONDUCTED. RESULTS - THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ADDITIONAL DEVICES IMPLANTED AND INVOLVED IN THIS EVENT: PXT261218/05840441, PXC121000/05922509, PCX201400/05945093, PXA260300/05903425, PXA260300/05903424, PXL161407/05897854, PXC161000/7051805.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THIS PATIENT UNDERWENT TREATMENT FOR AN ABDOMINAL AORTIC ANEURYSM AND BILATERAL ILIAC ARTERY ANEURYSMS WITH SEVEN GORE EXCLUDER AAA ENDOPROSTHESES. COIL EMBOLIZATION OF THE LEFT HYPOGASTRIC ARTERY WAS ALSO PERFORMED. ON (B)(6) 2008, A CAT SCAN IDENTIFIED A TYPE II ENDOLEAK, REPORTEDLY ATTRIBUTED TO THE LEFT HYPOGASTRIC ARTERY THAT WAS NOT FULLY OCCLUDED DURING THE INITIAL PROCEDURE. ON (B)(6) 2009, A FOLLOW-UP ULTRASOUND SHOWED THE PATIENT STILL HAD A TYPE II ENDOLEAK, AND THE ANEURYSM HAD ENLARGED FROM 5.8 CM TO 6.5 CM. ON (B)(6) 2009, AN ARTERIOGRAM SHOWED THE PATIENT HAD A TYPE I ENDOLEAK ORIGINATING FROM THE LEFT ILIAC ARTERY AND A TYPE II COMING FROM A LUMBAR ARTERY. ON AN UNK DATE, FOLLOW-UP IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK AND ANEURYSM ENLARGEMENT ASSOCIATED WITH THE AORTIC EXTENDER COMPONENT IMPLANTED ON THE LEFT SIDE. IT WAS ALSO REPORTED THAT THE PATIENT'S RIGHT ILIAC ARTERY ANEURYSM HAD ENLARGED. ON (B)(6) 2009, AN INTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK. AN ADDITIONAL GORE EXCLUDER AAA ENDOPROSTHESIS WAS IMPLANTED ON THE PATIENT'S LEFT SIDE. FINAL ANGIOGRAPHY DEMONSTRATED RESOLUTION OF THE TYPE I ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2010, AN ADDITIONAL PROCEDURE WAS PERFORMED TO TREAT THE TYPE I ENDOLEAK AND BILATERAL ILIAC ARTERY ANEURYSM ENLARGEMENT. THE PHYSICIAN REMOVED THE LEFT HYPOGASTRIC ARTERY THAT HAD PREVIOUSLY BEEN COIL EMBOLIZED. AS THE PATIENT'S ANATOMY WAS REPORTEDLY DISEASED AND ANEURISMAL, THE PHYSICIAN DECIDED TO EXPLANT ALL DEVICES AND REPAIR THE AORTA AND ILIAC ARTERIES WITH SURGICAL GRAFTS (MANUFACTURER UNK). THE PATIENT TOLERATED THE PROCEDURE.

    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 05903426

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| R