BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY

    MDR report key: 3201373 · Received June 27, 2013

    Report

    Report Number
    9680654-2013-00005
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    May 29, 2013
    Report Date
    June 26, 2013
    Manufacturer
    WILLIAM COOK AUSTRALIA
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    ENDOVASCULAR REPAIR OF AAA USING A FENESTRATED STENT-GRAFT. IT WAS KNOWN AHEAD OF TIME THAT THE CASE COULD BE CHALLENGING DUE TO CALCIFIED AORTIC NARROWING. THE PHYSICIAN AND PT ELECTED TO DO THE CASE WITH POSSIBLE UNDESIRABLE OUTCOME. NOT ABLE TO CANNULATE THE RIGHT RENAL ARTERY. MANY ATTEMPTS WITH DIFFERENT SELECTIVE WIRES, CATHETERS, AND ANGIO BALLOONS FAILED. THIS RESULTED IN A COVERED RENAL ARTERY, WITH LITTLE TO NO FLOW AT THE END OF THE PROCEDURE. THE PT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. THE PT IS DOING WELL AND WAS DISCHARGED 2 DAYS AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    292920 ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT PROXIMAL BODY NONE MIH WILLIAM COOK AUSTRALIA NA AC919399

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability