BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCUALR GRAFT

    MDR report key: 1030039 · Received April 15, 2008

    Report

    Report Number
    1820334-2008-00228
    Event Type
    Injury
    Date Received
    April 15, 2008
    Date of Event
    March 16, 2008
    Report Date
    March 16, 2008
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: STILL UNDER INVESTIGATION.

    Description of Event or Problem · 1

    A MALE PT OF UNK AGE UNDERWENT INITIAL AAA REPAIR IN 2008. ONE FLEX MAIN BODY AND TWO ILIAC LEG GRAFTS WERE PLACED. THE PT HAD SEVERE ANGULATION, SO THERE WAS A SEVERE TYPE I ENDOLEAK. A MAIN BODY EXTENSION WAS PLACED, AND THERE WAS STILL AN ENDOLEAK SO THE PHYSICIAN COIL EMBOLIZED. THEN THREE DAYS LATER, THE PT HAD A LOSS IN BLOOD PRESSURE, SO A CT WAS PERFORMED. IT WAS NOTICED THAT BELOW THE LEFT RENAL THERE WAS A RUPTURE AND BLOOD WAS GOING INTO THE PERITONEAL CAVITY. THE PT WAS NOT A CANDIDATE FOR AN OPEN PROCEDURE. ANOTHER MFR'S STENT WAS PLACED, AND THIS DID NOT STOP THE FLOW, SO THE PHYSICIAN PLACED ANOTHER MAIN BODY EXTENSION, WHICH COMPROMISED THE LEFT RENAL ARTERY. WITHIN 24 HRS THE PT HAD GOOD URINE OUTPUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCUALR GRAFT MIH ENDOVASCULAR GRAFT MIH COOK, INC. NA 2034529

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention