BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE® EXCLUDER® AAA ENDOPROSTHESIS

    MDR report key: 4120490 · Received September 26, 2014

    Report

    Report Number
    2953161-2014-00106
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 31, 2014
    Report Date
    August 31, 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

    PER THE GORE® EXCLUDER® AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU), ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE, BUT ARE NOT LIMITED TO ANEURYSM ENLARGEMENT AND MIGRATION. A REVIEW OF THE MANUFACTURING RECORDS FOR THE DEVICES VERIFIED THAT THE LOTS MET ALL PRE-RELEASE SPECIFICATIONS.

    Description of Event or Problem · 1

    ON (B)(6) 2008, THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AN ABDOMINAL AORTIC ANEURYSM WITH A RIGHT COMMON ILIAC ARTERY ANEURYSM AND A LEFT INTERNAL ILIAC ARTERY (IIA) ANEURYSM USING GORE® EXCLUDER® AAA ENDOPROSTHESES (PXT281218/05139031, PXC121400/05239742, AND PXA280300/04520536). THE BOTH LEGS WERE LANDED IN THE EXTERNAL ILIAC ARTERIES (EIAS), AND A BYPASS WAS MADE FROM THE RIGHT IIA TO THE RIGHT EIA. COIL EMBOLIZATION WAS INITIALLY PLANNED FOR THE LEFT IIA. HOWEVER, IT WAS REPORTEDLY DIFFICULT TO ADVANCE THE CATHETER INTO THE ARTERY. THEREFORE, THE LEFT IIA WAS SIMPLY COVERED BY PXC121400 WITHOUT BEING EMBOLIZED. THE FINAL ANGIOGRAM SHOWED NO ENDOLEAK AND THE PROCEDURE CONCLUDED. THE PREOPERATIVE ANEURYSM DIAMETER MEASURED 55MM. ON UNKNOWN DATE, FOLLOW-UP IMAGES SHOWED THE DISCONNECTION OF THE PXT281218 AND THE PXA280300. THERE WAS REPORTEDLY A MIGRATION OF PXT281218 TOWARDS THE ANEURYSM SAC. NO TYPE III ENDOLEAK WAS IDENTIFIED; THEREFORE, A RE-INTERVENTION WAS PLANNED FOR A LATER DATE. ON (B)(6) 2014, THE PATIENT PRESENTED WITH AN ABDOMINAL PAIN AND WAS DIAGNOSED WITH AN IMPENDING RUPTURE OF THE ABDOMINAL AORTIC ANEURYSM. THE ANEURYSM DIAMETER MEASURED 70MM. NO ENDOLEAK WAS IDENTIFIED. THREE GORE® EXCLUDER® AORTIC EXTENDER ENDOPROSTHESES WERE IMPLANTED AT THE DISCONNECTED JUNCTION OF THE PXT281218 AND THE PXA280300. THE PATIENT TOLERATED THE PROCEDURE. IT WAS REPORTED THAT THE MIGRATION OF THE DEVICE OCCURRED DUE TO THE DILATION OF THE PROXIMAL NECK, WHICH WAS DUE TO THE ANEURYSM ENLARGEMENT AS A RESULT OF A POSSIBLE TYPE II ENDOLEAK FROM THE LEFT IIA. THE RE-INTERVENTION REPAIRED ONLY THE DISCONNECTION OF THE DEVICES THIS TIME. THE PHYSICIAN IS CONSIDERING THE TREATMENT ON THE LEFT IIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600627 GORE® EXCLUDER® AAA ENDOPROSTHESIS SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 05139031

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Hospitalization| R PXC121400/05239742 AND PXA280300/04520536