BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2193334 · Received July 28, 2011

    Report

    Report Number
    1820334-2011-00404
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    January 28, 2011
    Report Date
    June 28, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    OCCLUSION IS ADDRESSED IN THE IFU. EVAL: EVENT IS STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A FEMALE PT UNDERWENT EMERGENCY ABDOMINAL AORTIC ANEURYSM REPAIR. ACCESSING THE PATIENT'S FEMORAL ARTERY, THE ENDOVASCULAR STENT GRAFTS WERE DELIVERED OVER TWO LUNDERQUIST WIRE GUIDES (260CM). THE PROCEDURE WENT SMOOTHLY CONSIDERING THAT THIS WAS AN EMERGENT SITUATION, ALL DEVICES WERE INTRODUCED AND DEPLOYED IN THEIR INTENDED POSITIONS WITH ADEQUATE OVERLAP BETWEEN THE MAIN BODY AND THE ILIAC LIMB EXTENSIONS. UPON REGULAR F/U COMPUTED TOMOGRAPHY ANGIOGRAPHY OF THIS PATIENT'S ENDOVASCULAR DEVICE, IT WAS DISCOVERED THAT THE PATIENT'S LEFT COMMON ILIAC STENT GRAFT WAS SIGNIFICANTLY COMPRESSED (AT THE LEVEL OF THE CONTRALATERAL ILIAC JUNCTION) AND HAD THROMBOSED THE LIMB. UPDATED INFO REC'D ON (B)(6) 2011: THE PHYSICIAN DID NOT NOTICE COMPRESSION ON 30 DAY F/U COMPUTED TOMOGRAPHY ANGIOGRAPHY. NO ADD'L PROCEDURE HAS BEEN PERFORMED OR SCHEDULED, PHYSICIAN WILL MONITOR PT. THE PT HAS SMALL VESSELS AND THERE WAS CALCIUM PRESENT.

    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 2479269

    Patients

    Seq Age Sex Outcome Treatment
    1