BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2211312 · Received August 3, 2011

    Report

    Report Number
    1820334-2011-00411
    Event Type
    Injury
    Date Received
    August 3, 2011
    Date of Event
    June 1, 2011
    Report Date
    July 7, 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)() - OCCLUSION IS LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A MALE PT UNDERWENT AAA AND COMMON ILIAC ARTERY ANEURYSM REPAIR. A MAIN BODY AND TWO ILIAC LEGS FOR LEFT SIDE AND TWO ILIAC LEGS FOR RIGHT SIDE WERE PLACED. REGARDING RIGHT SIDE, ILIAC LEGS WERE EXTENDED INTO EXTERNAL ILIAC ARTERY. IN (B)(6) 2011 (EXACT DATE UNK), THE PT CLAIMED PAIN OF LOWER EXTREMITY EVEN WHEN SEATED POSITION OR STANDING POSITION AT ANOTHER MED FACILITY. ON (B)(6) 2011, THE PT VISITED THIS FACILITY AND IT WAS CONFIRMED THE RIGHT ILIAC LEGS WERE OCCLUDED WITH THROMBUS. THROMBUS IN THE RIGHT ILIAC LEGS WERE REMOVED WITH A BALLOON CATHETER AND ANOTHER MFR'S STENTS (12MM6CM AND 8MM8CM) WERE PLACED. BLOOD FLOW TO LOWER EXTREMITY WAS OBSERVED. THE PT WAS FINE 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 F2534372

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention