BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2992879 · Received March 1, 2013

    Report

    Report Number
    1820334-2013-00110
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 8, 2013
    Report Date
    February 8, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PT WEIGHT: UNK AS NOT PROVIDED BY REPORTER. (B)(4) - DIFFICULTY CANNULATING IS NOT SPECIFICALLY LABELED IN THE IFU. EVENT. EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE WITH VASCULAR DISEASE, AAA, AND A PREVIOUSLY PLACED COMMON ILIAC STENT, UNDERWENT AN EVAR ON (B)(6) 2013. THE PHYSICIAN CAME FROM THE ARM AND GOT THROUGH THE GATE, SNARED THE WIRE BUT WAS UNABLE TO GET THE LIMB THROUGH THE GATE. THE PHYSICIAN CONVERTED MAIN BODY TO AN AORTA UNI-ILIAC AND PROCEEDED JUST FINE. THE PHYSICIAN PERFORMED A FEM-FEM BYPASS. THE PT TOLERATED THE PROCEDURE WELL. NO HARM TO THE PT. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89378 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA 3819408

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention