BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT ILIAC LEG

    MDR report key: 2132183 · Received June 14, 2011

    Report

    Report Number
    1820334-2011-00315
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 17, 2011
    Report Date
    May 17, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) NO PT OUTCOME WAS PROVIDED BY THE RPTR. (B)(4) HOLES IN THE GRAFT MATERIAL ARE NOT SPECIFICALLY LABELED IN THE IFU. EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    AN (B)(6) MALE UNDERWENT AAA REPAIR ON (B)(6) 2011. THE PT HAD SOME TORTUOSITY BUT NOT RELEVANT TO THE CASE. DOCTORS DEPLOYED AN ILIAC LEG GRAFT ON THE LEFT COMMON ILIAC (CONTRALATERAL SIDE) AND AT THE END OF THE CASE A FINAL ANGIOGRAM WAS PERFORMED AND A LEAK WAS NOTICED COMING FROM THE MIDDLE SECTION OF THE LEFT LEG IMPLANTED, BOTH TYPE 1B AND TYPE 2 ENDOLEAKS WERE RULED OUT AND AFTER SOME CONSIDERATION AND DISCUSSIONS ANOTHER ILIAC LEG GRAFT WAS IMPLANTED. AFTER THE ILIAC LEG WAS IMPLANTED, THE LEAK WAS IMMEDIATELY GONE. CONCLUSION, THERE WAS A TEAR IN THE FABRIC OR GAP BETWEEN THE LAST TWO Z-STENT IN THE FIRST ILIAC LEG GRAFT THAT WAS DEPLOYED ON THE LEFT SIDE. NO PT OUTCOME WAS PROVIDED BY THE RPTR. NO IMAGES ARE PROVIDED. NO ADDITIONAL MEDICAL PROCEDURES WERE REQUIRED DUE TO THIS OCCURRENCE. THE PT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OBSERVATION.

    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 2436224

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention