BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3252355 · Received July 23, 2013

    Report

    Report Number
    2017233-2013-00484
    Event Type
    Injury
    Date Received
    July 23, 2013
    Date of Event
    June 26, 2013
    Report Date
    July 11, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ON (B)(6) 2009, THE PATIENT UNDERWENT TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM WITH THREE GORE EXCLUDE AA ENDOPROSTHESIS. ON (B)(6) 2013, FOLLOW-UP IMAGING IDENTIFIED A DISTAL TYPE I ENDOLEAK WITH ANEURYSM ENLARGEMENT OF 2.7 CM. IT WAS REPORTED THE CAUSE OF THE ENDOLEAK WAS DISEASE PROGRESSION OF THE LEFT COMMON ILIAC ARTERY. THIS REPORTEDLY RESULTED IN REMODELING OF THE ANEURYSM AND A LOSS OF DEVICE APPOSITION. IT WAS ALSO REPORTED THE CONTRALATERAL LEG COMPONENT HAD MIGRATED PROXIMALLY (AMOUNT UNKNOWN) INTO THE ANEURYSM SAC RESULTING IN THE DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT ANEURYSM ENLARGEMENT OF 2.7 CM. HAS OCCURRED AS A RESULT OF THE ENDOLEAK. ON (B)(6) 2013, AN INTERVENTION WAS PERFORMED TO TREAT THE DISTAL TYPE I ENDOLEAK. THE LEFT INTERNAL ILIAC ARTERY WAS FIRST COIL EMBOLIZED PRIOR TO PREVENT RETROGRADE FLOW, AND THREE ADDITIONAL DEVICES WERE IMPLANTED FOR ADDITIONAL EXTENSION. A CONTRALATERAL LEG COMPONENT WAS FIRST IMPLANTED PROXIMAL TO THE LEVEL OF THE FLOW DIVIDER ON THE LEFT CONTRALATERAL SIDE. A ILIAC EXTENDER COMPONENT WAS THEN IMPLANTED FOR DISTAL EXTENSION ON THE LEFT SIDE. FINALLY, ANOTHER ILIAC EXTENDER COMPONENT WAS IMPLANTED FOR DISTAL LENGTH PAST THE LEFT INTERNAL ILIAC. THE LEFT INTERNAL ILIAC WAS EMBOLIZED PRIOR TO IMPLANTING THE THREE DEVICES TO PREVENT RETROGRADE FLOW. FINAL ANGIOGRAPHY SHOWED RESOLUTION OF THE DISTAL TYPE I ENDOLEAK, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    342126 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 05069092

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Hospitalization| R COREG| LIPITOR| PLAVIX