BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GORE EXCLUDER AAA ENDOPROSTHESIS

    MDR report key: 3221089 · Received July 3, 2013

    Report

    Report Number
    2953161-2013-00099
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    March 20, 2012
    Report Date
    June 11, 2013
    Manufacturer
    W. L. GORE & ASSOCIATES
    Product Code
    MIH
    PMA / PMN Number
    P020004
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MFG RECORDS FOR THE DEVICE(S) VERIFIED THAT THE LOT(S) MET ALL PRE-RELEASE SPECIFICATIONS. THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE (IFU) STATES: THE SAFETY AND EFFECTIVENESS OF THE GORE EXCLUDER AAA ENDOPROSTHESIS HAS NOT BEEN EVALUATED IN THE FOLLOWING PT POPULATION: -REVISION OF PREVIOUSLY PLACED STENT GRAFTS. ADDITIONALLY, THE IFU STATES: ADVERSE EVENTS THAT MAY OCCUR AND / OR REQUIRE INTERVENTION INCLUDE BUT ARE NOT LIMITED TO: OCCLUSION OF DEVICE OR NATIVE VESSEL, CLAUDICATION. ADDITIONALLY, THE IFU STATES: ACCORDING TO THE GORE EXCLUDER AAA ENDOPROSTHESIS INSTRUCTIONS FOR USE, PTS SHOULD BE COUNSELED AS TO THE POSSIBILITY OF SUBSEQUENTLY REINTERVENTIONS INCLUDING CATHETER BASED AND OPEN SURGICAL CONVERSATION.

    Description of Event or Problem · 1

    ON AN UNK DATE IN 2011 THIS PT UNDERWENT TREATMENT FOR A RIGHT COMMON ILIAC ANEURYSM WITH UNK ENDOPROSTHESES. ON (B)(6) 2012, THIS PT UNDERWENT REINTERVENTION TO TREAT A TYPE IV ENDOLEAK CAUSED BY A RUPTURE OF THE PREVIOUSLY PLACED "UNK" ENDOPROSTHESIS. A GORE EXCLUDER AORTIC EXTENDER COMPONENT WAS ADVANCED WITHIN THE PREVIOUS "UNK" ENDOPROSTHESIS AND LANDED JUST DISTAL TO THE RENAL ARTERIES. TWO GORE EXCLUDER CONTRALATERAL LEG COMPONENTS WERE THEN IMPLANTED SIDE BY SIDE WITHIN THE AORTIC EXTENDER COMPONENT, EXTENDING DISTALLY AND RELINING EACH COMMON ILIAC ARTERY, TO A LEVEL JUST PROXIMAL OF THE HYPOGASTRIC ARTERIES ON BOTH THE RIGHT AND LEFT SIDE. POST PROCEDURE, IT WAS DETERMINED THAT THERE WAS AN OCCLUSION OF THE PT'S LEFT INFERIOR LIMB AT THE FEMORAL ARTERY ACCESS SITE. AN ENDARTERECTOMY AND EMBOLECTOMY OF THE LEFT COMMON FEMORAL ARTERY WAS PERFORMED. GOOD FLOW WAS RESTORED TO THE ARTERY WITH NO THROMBOSIS OF THE GRAFT. THE PT TOLERATED THE PROCEDURE. THE OCCLUSION IS THOUGHT TO HAVE BEEN CAUSED BY THE ATHEROSCLEROTIC DISEASE OF THE PT'S COMMON FEMORAL ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303516 GORE EXCLUDER AAA ENDOPROSTHESIS MIH / SYSTEM ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH W. L. GORE & ASSOCIATES 9153324

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Hospitalization| O| R PXC141400/9707517| PXC141400/9707508