BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2161719 · Received July 8, 2011

    Report

    Report Number
    1820334-2011-00359
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 8, 2011
    Report Date
    June 9, 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

    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 AT 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. IT APPEARS THAT THE DEVICE WAS USED OUTSIDE THE IFU IN MULTIPLE WAYS. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. NO ADDITIONAL ACTIONS REQUIRED AT THIS TIME AS THE RISK IS INSUFFICIENT PER QERA.

    Description of Event or Problem · 1

    AN (B)(6) MALE PT UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT'S ANATOMICAL FORM WAS NOT SUITABLE FOR THE PROCEDURE - AN ANGLE OF PROXIMAL NECK WAS MORE THAN 60 DEGREES RELATIVE TO THE LONG AXIS OF THE ANEURYSM. HOWEVER BECAUSE THE PT HAD MODERATE AORTIC VALVE STENOSIS AFTER PCI DUE TO ANGINA, THIS PROCEDURE WAS ATTEMPTED AND CONDUCTED AS LABELED. WHEN MAIN BODY WAS INSERTED, PROXIMAL NECK GOT SHORTENED. THEREFORE, THE PHYSICIAN DECIDED THE PLACING POSITION A LITTLE BELOW RENAL ARTERIES. ANGIOGRAPHY SHOWING RIGHT CIA REVEALED THAT LENGTH TO IIA WAS NOT LONG ENOUGH TO PLACE ILIAC LEG BECAUSE MAIN BODY WAS PLACED A BIT LOWER DUE TO SHORTENING OF PROXIMAL NECK. THE RIGHT ILIAC LEG WAS PLACED WITH AN ATTEMPT TO PUSH UP THE MAIN BODY, BUT THE ILIAC LEG OCCLUDED IIA. SINCE PROXIMAL TYPE I ENDOLEAK WAS OBSERVED, BODY EXTENSION WAS ADDITIONALLY PLACED TO PROXIMAL NECK AND TOUCH-UP BY CODA WAS ATTEMPTED. MAJOR LEAKAGE FROM PROXIMAL NECK (TYPE I) WAS SOLVED BUT ANOTHER LEAKAGE WAS CONFIRMED. THE PHYSICIAN JUDGED ANOTHER LEAKAGE AS TYPE II ENDOLEAK. REGARDING RIGHT IIA OCCLUSION, BLOOD FLOW WAS CONFIRMED BECAUSE MAIN BODY WAS PUSHED UP BY DELIVERY SYSTEM OF BODY EXTENSION. THERE HAS BEEN NO PT OUTCOME PROVIDED 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 F2539747

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention