BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2820625 · Received October 30, 2012

    Report

    Report Number
    1820334-2012-00482
    Event Type
    Injury
    Date Received
    October 30, 2012
    Date of Event
    September 6, 2012
    Report Date
    October 2, 2012
    Manufacturer
    COOK INC
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    LOT AND EXPIRATION - UNK AS NOT PROVIDED BY REPORTER. (B)(4). EVENT EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A FEMALE PT HAD A AAA REPAIR USING A COOK ZENITH GRAFT AND LIMBS ON (B)(6) 2008. CORRECT STENT OVERLAP ON CONTRALATERAL SIDE. DISCOVERED TO HAVE A DISLOCATION OF THE CONTRALATERAL LIMB IN (B)(6) 2012. REPAIRED WITH A BRIDGING LIMB ON (B)(6) 2012. NO ADDITIONAL INFO HAS BEEN PROVIDED BY THE REPORTER. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURSYM TREATMENT MIH COOK INC NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention