BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 3910875 · Received July 2, 2014

    Report

    Report Number
    2017233-2014-00347
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    September 19, 2012
    Report Date
    July 7, 2014
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IMAGES PROVIDED DID NOT ALLOW FOR EVALUATION IN RELATION TO THE EVENT. ADDITIONAL IMAGES HAVE BEEN REQUESTED BUT NOT AVAILABLE. WITH INFORMATION AND IMAGES PROVIDED, GORE IS UNABLE TO DETERMINE THE ROOT CAUSE OF THIS INCIDENT. ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND/OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO OCCLUSION OF DEVICE OR NATIVE VESSEL.

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICE IS BEING CONDUCTED. ALSO IMPLANTED: RMT311413/10220967.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS NO PRESENCE OF THROMBUS AND CALCIFICATION, AND THE PATIENT HAD AN ADEQUATE ANATOMY. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED A CLAUDICATION AND A GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DELIVERY SYSTEM WAS OCCLUDED ON THE LEFT SIDE. ACCORDING TO THE PHYSICIAN, THE CLAUDICATION WAS DUE TO THE DEVICE THROMBOSIS. THE CAUSE OF THE DEVICE OCCLUSION IS UNKNOWN.

    Description of Event or Problem · 1

    ON (B)(6) 2012, THE PATIENT WAS IMPLANTED WITH GORE® EXCLUDER® ENDOPROSTHESES TO TREAT AN ABDOMINAL AORTIC ANEURYSM. THE CAT ((B)(6) 2012) AND ULTRASOUND ((B)(6) 2012) CONFIRMED NO COMPLICATIONS. THE ANEURYSM SIZE WAS 50MM. IT WAS REPORTED THAT ON (B)(6) 2012, THE PATIENT EXPERIENCED A CLAUDICATION AND THE GORE® EXCLUDER® ENDOPROSTHESIS CONTRALATERAL LEG COMPONENT IMPLANTED AT THE LEFT SIDE WAS OCCLUDED. ACCORDING TO THE PHYSICIAN, THE CLAUDICATION IS DUE TO THE THROMBOSIS OF THE CONTRALATERAL LEG COMPONENT. ON (B)(6) 2012, THE PATIENT UNDERWENT A FEM-FEM BYPASS PROCEDURE. NO FURTHER ADVERSE EVENTS HAVE BEEN REPORTED. THE PATIENT TOLERATED THE PROCEDURE. THE 6 MONTHS AND 1YEAR FOLLOW UP EXAMS SHOWED THAT THERE WERE NO COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388254 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10220967

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R