BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2162145 · Received July 7, 2011

    Report

    Report Number
    1820334-2011-00356
    Event Type
    Injury
    Date Received
    July 7, 2011
    Date of Event
    June 7, 2011
    Report Date
    June 8, 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)(4) - OCCLUSION IS LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN (B)(6) MALE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF ABDOMINAL AORTIC ANEURYSM AND RIGHT COMMON ILIAC ARTERY ANEURYSM ON (B)(6) 2011. THE PATIENT'S ANATOMICAL FORM WAS SUITABLE FOR THE PROCEDURE. THE RIGHT INTERNAL ILIAC ARTERY WAS INITIALLY EMBOLIZED WITH COILS. AFTER DEPLOYMENT OF THE MAIN BODY, CONTRALATERAL LIMB CANNULATION FAILED. THE PHYSICIAN ATTEMPTED TO ADVANCE A WIRE GUIDE THROUGH THE BRACHIAL ARTERY USING PULL-THROUGH TECHNIQUE, HOWEVER, OCCLUSION OF THE CONTRALATERAL GATE WAS CONFIRMED. THE PHYSICIAN DECIDED TO CONVERT A BIFURCATED GRAFT INTO AN AORTO-UNIILIAC GRAFT AND PLACED A ZENITH CONVERTER IN THE MAIN BODY AND A ZIP ON THE CONTRALATERAL SIDE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA F2612614

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention