BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4243613 · Received November 11, 2014

    Report

    Report Number
    2017233-2014-00589
    Event Type
    Injury
    Date Received
    November 11, 2014
    Date of Event
    October 14, 2014
    Report Date
    November 16, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICATIONS: SYNTHROID, METOPROLOL, SYNTHREX. THE REVIEW OF THE MANUFACTURING PAPERWORK VERIFIED THAT THIS LOT MET ALL PRE-RELEASE SPECIFICATIONS. ACCORDING TO THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, ADVERSE EVENTS WHICH MAY OCCUR AND REQUIRE INTERVENTION INCLUDE ANEURYSM GROWTH AND ENDOLEAK.

    Description of Event or Problem · 1

    ON (B)(6) 2010, THE PATIENT WAS IMPLANTED WITH FOUR GORE® EXCLUDER® AAA ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT DURING A FOLLOW UP COMPUTED TOMOGRAPHY (CT) A LEFT COMMON ILIAC ANEURYSM WAS IDENTIFIED WITH A DISTAL TYPE I ENDOLEAK PRESENT. THE PHYSICIAN STATED THAT THE ARTERY WAS DISEASED DURING THE INITIAL IMPLANT IN 2010. THERE WAS A REINTERVENTION PERFORMED DUE TO THE ANEURYSM SAC ENLARGING (AMOUNT IS UNKNOWN) AND TO EXCLUDE THE ILIAC ANEURYSM. THE PHYSICIAN REINTERVENED ON (B)(6) 2014, AND PERFORMED A ¿BRAZILIAN SNORKEL¿ PROCEDURE. LEFT BRACHIAL ARTERY ACCESS WAS OBTAINED AND A VIABAHN 13MMX10CM WAS ADVANCED THROUGH A CONTRALATERAL LEG 18MMX9.5CM DEVICE AND THE DISTAL PART OF IT WAS PLACED IN THE LEFT INTERNAL ILIAC ARTERY WITH THE PROXIMAL PART REMAINING IN THE CONTRALATERAL LEG. THERE WAS ACCESS THROUGH THE LEFT FEMORAL ARTERY AND AN EXCLUDER CONTRALATERAL LEG 14MMX10MM WAS ADVANCED INTO THE LEFT EXTERNAL ILIAC ARTERY AND CONTRALATERAL LEG. THE VIABAHN AND EXCLUDER CONTRALATERAL LEG WERE PLACED SIDE-BY-SIDE (OR ¿SANDWICHED¿) INSIDE THE PREVIOUSLY PLACED CONTRALATERAL LIMB AND DEPLOYED AT THE SAME TIME. THE VIABAHN WAS DEPLOYED IN THE CONTRALATERAL LEG AND INTERNAL ILIAC ARTERY AND THE EXCLUDER CONTRALATERAL LEG WAS DEPLOYED IN THE PREVIOUSLY DEPLOYED CONTRALATERAL LEG AND THE EXTERNAL ILIAC ARTERY. BALLOONING WAS DONE AND THE ANEURYSM WAS EXCLUDED AND PATENCY WAS ACHIEVED. THE PATIENT TOLERATED THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON OR ABOUT (B)(6) 2014, COMPUTED TOMOGRAPHY SCAN REPORTEDLY IDENTIFIED A DISSECTION IN THE LEFT EXTERNAL ILIAC ARTERY. THE CAUSE OF THE DISSECTION IS UNKNOWN. THE IMAGES ARE NOT AVAILABLE. ON (B)(6) 2014, THE PHYSICIAN EXTENDED THE EXISTING STENT GRAFT SYSTEM BY IMPLANTING AN ADDITIONAL CONTRALATERAL LEG COMPONENT ((B)(4)). THE DISSECTION WAS RESOLVED, AND THE PATIENT TOLERATED THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    727824 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 8105987

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention