BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3895631 · Received June 25, 2014

    Report

    Report Number
    2017233-2014-00338
    Event Type
    Injury
    Date Received
    June 25, 2014
    Date of Event
    May 29, 2014
    Report Date
    May 29, 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

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

    Description of Event or Problem · 1

    ON (B)(6) 2014, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS. PRIOR TO THE IMPLANTATION OF A TRUNK IPSI-LATERAL LEG COMPONENT (RMT281218J/11970883), COIL EMBOLIZATION PROCEDURE WAS PERFORMED IN THE RIGHT INTERNAL ILIAC ARTERY. THE TRUNK WAS DEPLOYED, AND A CONTRA-LATERAL LEG COMPONENT (PLC231200J/12477309) WAS IMPLANTED IN A BALLERINA MANNER USING A CROSS-OVER TECHNIQUE. AFTER THE DEPLOYMENT OF THE STENT GRAFTS, A TYPE II ENDOLEAK WAS CONFIRMED, BUT THE PHYSICIAN DECIDED TO TAKE A WAIT-AND-WATCH APPROACH IN REGARD TO THE TYPE II ENDOLEAK AND COMPLETED THE PROCEDURE. A FOLLOW-UP COMPUTED TOMOGRAPHY (CT) REVEALED THAT THE DISTAL END OF THE TRUNK HAD BEEN MIGRATED APPROXIMATELY 2 CM PROXIMALLY TO THE ANEURISMAL SAC, CAUSING A DISTAL TYPE I ENDOLEAK. ON MAY 29, 2014, A CONTRA-LATERAL LEG COMPONENT (PLC231400J / 12383830) WAS IMPLANTED TO EXTEND THE DISTAL LENGTH OF THE STENT GRAFT TO THE RIGHT COMMON ILIAC ARTERY. IT WAS REVEALED THAT THE DISTAL TYPE I ENDOLEAK WAS RESOLVED POST PROCEDURE. THE SMALL TYPE II ENDOLEAK HAS STILL PERSISTED, BUT AN ADDITIONAL PROCEDURE HAS NOT BEEN PLANNED TO TREAT THE ENDOLEAK. IT WAS REPORTED THAT THE PHYSICIAN BELIEVES THAT SINCE THE CONTRA-LATERAL LEG WAS IMPLANTED IN A BALLERINA STYLE, THE DISTAL LEG OF THE TRUNK HAD A TORQUE WHICH COULD HAVE CAUSED THE MIGRATION OF THE STENT GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371619 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 11970883

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Hospitalization| R PLC231200J/12477309