BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 4960499 · Received August 3, 2015

    Report

    Report Number
    1820334-2015-00492
    Event Type
    Injury
    Date Received
    August 3, 2015
    Date of Event
    November 22, 2014
    Report Date
    July 16, 2015
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LOT # UNKNOWN AS NOT PROVIDED. EXP. DATE UNKNOWN AS NO LOT # WAS PROVIDED. UDI # UNKNOWN AS NO LOT WAS PROVIDED. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) MALE PATIENT IN THE (B)(6) EXPERIENCED BOWEL OBSTRUCTION, ISCHEMIA OR FISTULA ON (B)(6) 2014 (267 DAYS POST PROCEDURE). THE PATIENT WAS TREATED ON (B)(6) 2014 FOR AN AORTIC ANEURYSM. THE MAXIMUM AORTIC DIAMETER WAS 57 MM. THE PROXIMAL NECK HAD A PARALLEL SHAPE WITH NO PLAQUE/THROMBUS. THE RIGHT ILIAC ARTERY HAD MILD TORTUOSITY, NO OCCLUSIVE DISEASE, AND NO CALCIFICATION. THE LEFT ILIAC ARTERY HAD MILD TORTUOSITY, MILD OCCLUSIVE DISEASE, AND MILD CALCIFICATION. THE PATIENT RECEIVED A 26 MM X 96 MM MAIN-BODY DEVICE, A 13 MM X 74 MM LEFT ILIAC LEG, AND A 13 MM X 90 MM RIGHT ILIAC LEG. THERE WAS NO DIFFICULTY DEPLOYING ANY OF THE COMPONENTS. NO OTHER PROCEDURES WERE PERFORMED AND NO ADDITIONAL DEVICES WERE USED. A MOLDING BALLOON WAS NOT USED DURING THE STUDY PROCEDURE. AT THE CONCLUSION OF THE PROCEDURE, THE DEVICES WERE PATENT WITH NO EXTERNAL COMPRESSION, FLOW-LIMITING KINKS, ENDOLEAKS, OR THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    504856 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR