BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2062575 · Received April 8, 2011

    Report

    Report Number
    1820334-2011-00170
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 2, 2011
    Report Date
    March 11, 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

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

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) MALE PT UNDERWENT AAA REPAIR. THE PT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE AND ONE MAIN BODY AND THREE ILIAC LEGS - ONE FOR IPSILATERAL SIDE AND TWO FOR CONTRALATERAL SIDE - WERE PLACED. ON (B)(6) 2011, THE PT WAS DISCHARGED FROM THE HOSPITAL. ON (B)(6) 2011, THE PT CLAIMED LEG PAIN. ON (B)(6) 2011, THE PT VISITED THE HOSPITAL AND CT WAS TAKEN. IT REVEALED THE CONTRALATERAL ILIAC LEGS WERE OCCLUDED. ON (B)(6) 2011, THE PT WAS ADMITTED INTO THE HOSPITAL. ON (B)(6) 2011, THROMBECTOMY WAS PERFORMED WITH ANOTHER MFR'S ARTERIAL EMBOLECTOMY CATHETER AND A THROMBUS ASPIRATION CATHETER. MOREOVER, ANOTHER MFR'S (10X57, 10X37, 10X25) EXPRESS STENTS AND ANOTHER MFR'S 12X60 STENT WERE PLACED INSIDE THE CONTRALATERAL ILIAC LEGS TO SECURE THROMBUS IN THE ILIAC LEGS AND DILATE THE ILIAC LEGS SINCE THEY WERE STENOSED. PATENCY OF THE ILIAC LEGS AND BLOOD FLOW TO LOWER EXTREMITY WERE CONFIRMED. IT IS UNK THE PT'S CONDITION AFTER THE PROCEDURE SINCE IT WAS NOT PROVIDED BY THE REPORTER.

    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 F2579285

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention