BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2062598 · Received April 8, 2011

    Report

    Report Number
    1820334-2011-00219
    Event Type
    Injury
    Date Received
    April 8, 2011
    Date of Event
    March 9, 2011
    Report Date
    March 9, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - DEATH IS LABELED IN THE IFU. (IT IS UNK IF ZENITH DEVICE CAUSED OR CONTRIBUTED TO THE PT DEATH). (B)(4) - ENDOLEAKS ARE LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, AN (B)(6) YEAR OLD MALE UNDERWENT AAA REPAIR. ANOTHER MFR'S GRAFT WAS PREVIOUSLY IMPLANTED. THE PHYSICIAN IMPLANTED A ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG AND A ZENITH RENU AAA ANCILLARY GRAFT CONVERTER. AN AREA REP WAS THERE FOR THE PROCEDURE AND IT APPEARED THE GRAFT DID NOT SEAL WELL, SO THE PHYSICIAN ATTEMPTED WITH DIFFICULTY, TO PLACE ANOTHER MFR'S STENT. THE PHYSICIAN ENDED UP SNARING THE OTHER MFR'S STENT AND REMOVING IT. THE AREA REP BELIEVES THE PHYSICIAN SHOT A RUN AFTER REMOVING THE STENT AND THE GRAFT SEALED. THE PT SUBSEQUENTLY EXPIRED, HOWEVER, AT THIS TIME, THE DATE OR CAUSE HAS NOT BEEN PROVIDED.

    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 2577380

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death| R