BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 2974122 · Received February 13, 2013

    Report

    Report Number
    2017233-2013-00067
    Event Type
    Injury
    Date Received
    February 13, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    W.L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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) 2013, THIS PT UNDERWENT ENDOVASCULAR REPAIR OF AN INTRARENAL ABDOMINAL AORTIC ANEURYSM USING GORE EXCLUDER AAA ENDOPROSTHESIS FEATURING C3 DEPLOYMENT SYSTEM. THE TRUNK-IPSILATERAL LEG COMPONENT WAS POSITIONED 5 MM DISTAL TO THE LOWEST RENAL ARTERY AND THE PROXIMAL END WAS DEPLOYED. DIGITAL SUBTRACTION ANGIOGRAPHY CONFIRMED CORRECT LOCATION. AFTER CANNULATION OF THE CONTRALATERAL GATE AND PIGTAIL ROTATION CONTROL AND VERIFICATION OF THE TRUNK-IPSILATERAL LEG COMPONENT POSITION, THE GUIDEWIRE WAS CHANGED TO A BACKUP MEIER WIRE. THEN THE SDV (B)(4) WAS INSERTED IN THE CONTRALATERAL GATE. THE TRUNK-IPSILATERAL LEG COMPONENT WAS THEN FULLY DEPLOYED. A CONTRALATERAL LEG COMPONENT (PXC161200) WAS THEN ADVANCED. HOWEVER, THE PHYSICIAN NOTED A RISK OF COVERING THE LEFT HYPOGASTRIC ARTERY. THEREFORE, THE PXC161200 WAS REMOVED AND A PXC161000 WAS PREPARED. THE INSERTION OF THE SHEATH INTO THE CONTRALATERAL GATE WAS DIFFICULT DUE TO RESISTANCE AND FRICTION. THE PXC161000 WAS DEPLOYED AND BALLOONED WITH A RELIANT BALLOON. FINAL ANGIOGRAPHY SHOWED THAT THE TRUNK-IPSILATERAL LEG COMPONENT HAD MOVED PROXIMALLY APPROXIMATELY 15 MM AND COVERED BOTH RENAL ARTERIES. THE PHYSICIAN ATTEMPTED TO PULL DOWN THE ENDOPROSTHESIS WITH A BALLOON, HOWEVER, THIS WAS NOT SUCCESSFUL. THE PHYSICIAN DECIDED TO CONVERT TO OPEN REPAIR. IT WAS NOTED THAT THE COMMON ILIAC AND EXTERNAL ILIAC ARTERIES WERE WITHOUT CALCIUM, OR SEVERE TORTUOSITY. THE PT IS DOING WELL AND THE KIDNEYS ARE WELL PERFUSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    64327 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W.L. GORE & ASSOCIATES 10584371

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention