BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2171353 · Received July 18, 2011

    Report

    Report Number
    1820334-2011-00393
    Event Type
    Injury
    Date Received
    July 18, 2011
    Date of Event
    June 29, 2011
    Report Date
    June 30, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - OCCLUSION IS LABELED IN THE IFU. NO PRODUCT OR IMAGES WERE RETURNED TO ASSIST WITH THIS INVESTIGATION. THIS PRODUCT LINE HAS ADDRESSED ALL DESIGN CONTROL REQUIREMENTS AND SHOWN THE DEVICE HAS MET THE PREDETERMINED REQUIREMENTS AND THAT THOSE REQUIREMENTS MEET THE NEEDS OF THE USER. EACH DEVICE IS SENT WITH AN IFU WHICH DESCRIBES THE INDICATIONS FOR USE, WARNINGS, PRECAUTIONS, SIZING INSTRUCTIONS, AND THE PROPER DEPLOYMENT SEQUENCE. SPECIFIC TO THIS CASE, THE IFU STATES: "UNLESS MEDICALLY INDICATED, DO NOT DEPLOY ZENITH FLEX AAA ENDOVASCULAR GRAFT IN A LOCATION THAT WILL OCCLUDE ARTERIES NECESSARY TO SUPPLY BLOOD FLOW ORGANS OR EXTREMITIES." "INCORRECT DEPLOYMENT OR MIGRATION OF ENDOPROSTHESIS MAY REQUIRE SURGICAL INTERVENTION." "INABILITY TO MAINTAIN PATENCY OF A LEAST ONE INTERNAL ILIAC ARTERY OR OCCLUSION OF AN INDISPENSABLE INFERIOR MESENTERIC ARTERY MAY INCREASE THE RISK OF PELVIC/BOWEL ISCHEMIA." THE FAILURE MODE ASSIGNED TO THIS CASE IS INACCURATE DEPLOYMENT. THIS FAILURE MODE WAS DETERMINED BASED ON THE PROVIDED EVENT DESCRIPTION AS WELL AS THE PHYSICIAN COMMENTS: "IT WAS DIFFICULT TO SEE THE BIFURCATION AREA OF LEFT INTERNAL ILIAC ARTERY SINCE TI WAS BEHIND OF ILIAC ARTERY AND NARROW ALTHOUGH C-ARM WAS USED." WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADD'L ACTIONS REQUIRED AT THIS TIME. THE RISK IS INSUFFICIENT PER QERA.

    Description of Event or Problem · 1

    A (B)(6) PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE ALTHOUGH THROMBUS WAS PARTIALLY OBSERVED IN PROXIMAL SITE AND PROXIMAL NECK ANGULATION WAS 50 DEGREES FOR INFRARENAL NECK TO AXIS OF AAA. MOREOVER, IT WAS CONFIRMED THAT THE PT SUFFERED FROM ISCHEMIC HEART DISEASE AND HYPERPIESIA. THE PROCEDURE WAS CONDUCTED AS LABELED BUT CONFIRMATORY ANGIOGRAPHY AFTER ILIAC LEG PLACEMENT REVEALED OCCLUSION OF LEFT INTERNAL ILIAC ARTERY. THE PHYSICIAN ATTEMPTED TO PUSH UP THE LEFT ILIAC LEG WITH A BALLOON CATHETER, BUT THE OCCLUSION WAS NOT RESOLVED AND THE PROCEDURE WAS COMPLETED. NO OTHER ADVERSE EFFECT TO THE PT WAS OBSERVED AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2629482

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Disability