BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2172040 · Received July 13, 2011

    Report

    Report Number
    1820334-2011-00371
    Event Type
    Death
    Date Received
    July 13, 2011
    Date of Event
    June 12, 2011
    Report Date
    June 14, 2011
    Manufacturer
    COOK INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION - UNKNOWN AS LOT IS UNKNOWN. (B)(4). DEATH IS LABELED IN THE IFU. RUPTURE IS LABELED IN THE IFU. EVENT EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PATIENT WITH A PREVIOUSLY PLACED ZENITH FLEX AAA ENDOVASCULAR GRAFT THAT HAD BEEN PLACED AT ANOTHER FACILITY IN (B)(6) OF 2009, WAS TAKEN INTO SURGERY ON (B)(6) 2011 FOR A RUPTURED ANEURYSM. THE PATIENT HAD A CT IN (B)(6) OF 2011 WITH NO ENDOLEAKS, GOOD PROXIMAL SEAL, NO SAC GROWTH. THE PHYSICIAN LEFT THE SUPRARENAL STENT AND THE PROXIMAL SEAL STENT IN PLACE AND SEWED AN OPEN GRAFT INTO PLACE AT THE BOTTOM OF THE PROXIMAL SEAL STENT. THE PHYSICIAN SAID THE PATIENT WAS COAGULOPATHIC AND DIED AFTER THE OPEN REPAIR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Death