BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 3231864 · Received July 9, 2013

    Report

    Report Number
    1820334-2013-00283
    Event Type
    Injury
    Date Received
    July 9, 2013
    Date of Event
    June 25, 2013
    Report Date
    June 25, 2013
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A (B)(6) YEAR OLD, MALE, UNDERWENT EVAR ON A PREVIOUS DATE. ONE MAIN BODY AND TWO ILIAC LEGS WERE PLACED. EVENTUALLY THE PT PRESENTED WITH AN ENDOLEAK. THE PHYSICIAN WAS UNSURE IF IT WAS A TYPE II OR TYPE III. ON (B)(6) 2013, THE PHYSICIAN THEN RELINED A LIMB ON AN EXISTING COOK ENDOGRAFT. DOCTOR ACCESSED THE LEFT ILIAC AND DID 3 DIFFERENT RUNS AT DIFFERENT ANGLES. HAD A BLUSH AT ONE OF THE LIMBS BUT SEEMED TO BE A TYPE II. HE PLACED ANOTHER LIMB IN THE AREA AND RELINED IT. BALLOONED WITH A 32 CODA BALLOON AND STILL HAD THE LATE BLUSH. IT IS IN THE AREA WHERE SOME COLLATERAL VESSELS ARE. CONCLUDED IT IS A TYPE II LEAK AND HE CLOSED THE ILIAC. NO ALTERATION TO THE GRAFT. OVERLAP OF EXISTING WAS GOOD. HE USED A LUNDERQUIST WIRE TO DELIVER THE LIMB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313442 ZENITH FLEX WITH SPIRAL-Z TECHNOLOGY AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIV ANEURYSM TREATMENT MIH COOK, INC. NA 3624002

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention