BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 3231844 · Received July 12, 2013

    Report

    Report Number
    1820334-2013-00291
    Event Type
    Injury
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    July 1, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    INFORMATION FROM A STUDY INDICATES THAT A (B)(6) MALE UNDERWENT EVAR ON (B)(6) 2013. THE PATIENT HAD WITH SEVERE LEFT ILIAC OCCLUSIVE DISEASE AND CALCIFICATION, WITH MODERATE LEFT ILIAC TORTUOSITY. HE ALSO HAD MODERATE RIGHT ILIAC OCCLUSIVE DISEASE AND TORTUOSITY WITH SEVERE RIGHT ILIAC CALCIFICATION. THE PHYSICIAN PLACED ZENITH ENDOGRAFTS WITH SPIRAL-Z TECHNOLOGY. IT WAS NOTED THAT BOTH THE LEFT AND THE RIGHT SPIRAL-Z LIMBS HAD EXTERNAL COMPRESSION. ADDITIONAL INFORMATION RECEIVED FROM THE STUDY ON (B)(6) 2013 INDICATES THAT: THERE WAS A RIGHT ANGIOPLASTY PERFORMED AFTER THE PROCEDURE IN THE NATIVE VESSEL. THE SITE INDICATED THAT AN ANGIOPLASTY OR STENT PLACEMENT WAS PERFORMED DUE TO EXTERNAL COMPRESSION ON THE RIGHT AND LEFT SIDE. THERE IS NO EVIDENCE OF EXTERNAL COMPRESSION OBSERVED AT THE OCCLUSION OF THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321567 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH COOK, INC. NA 4019153

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention