BEUDAMED
    FDA Adverse Event Other Summary report: N

    ZENITH RENU

    MDR report key: 2202713 · Received July 28, 2011

    Report

    Report Number
    2202713
    Event Type
    Other
    Date Received
    July 28, 2011
    Date of Event
    July 19, 2011
    Report Date
    July 26, 2011
    Manufacturer
    COOK MEDICAL
    Product Code
    MIH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE ZENITH RENU CONVERTER WAS PASSED OVER THE RIGID GUIDE WIRE AND POSITIONED JUST BELOW THE LEVEL OF THE RIGHT RENAL ARTERY. THE FIRST 2 STENTS WERE DEPLOYED AND AFTER VERIFYING POSITION, THE REMAINDER OF THE RENU CONVERTER GRAFT WAS DEPLOYED. ON FLUOROSCOPY, THE GRAFT APPEARED TO BE IN A GOOD POSITION AND NO KINKS OR ANY OTHER ABNORMALITY NOTED. PHYSICIAN THEN RELEASED THE RENU CONVERTER FROM THE PLACEMENT DEVICE BUT WAS NOT ABLE TO REMOVE THE DEVICE. IN ATTEMPTING TO REMOVE THE DEVICE, THE CONVERTER WAS PULLED DOWN INTO THE ANEURYSM. COOK REPRESENTATIVE CONFIRMED THAT ALL STEPS WERE FOLLOWED APPROPRIATELY IN ATTEMPTING TO DEPLOY THE DEVICE. CARRIER WAS THEN FULLY REMOVED, BUT IT WAS OBVIOUS TO THE PHYSICIAN THAT THE STENT GRAFT WAS NOT IN A GOOD POSITION AND THAT THERE WAS A KINK IN IT PREVENTING IT FROM FULLY DEPLOYING. PHYSICIAN FELT THAT THE DEVICE WAS NON-FUNCTIONAL. THE PHYSICIAN MADE THE DECISION TO CONVERT THE PROCEDURE TO AN OPEN REPAIR AND REMOVE THE STENT GRAFT. THE PATIENT TOLERATED THE PROCEDURE SATISFACTORILY AND WAS TRANSFERRED TO THE ICU IN STABLE BUT SERIOUS CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH RENU GRAFT, ENDOVASCULAR, AORTIC ANEURYSM MIH COOK MEDICAL * 2720334

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Other