BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1112727 · Received August 11, 2008

    Report

    Report Number
    9681442-2008-00121
    Event Type
    Malfunction
    Date Received
    August 11, 2008
    Date of Event
    June 27, 2008
    Report Date
    July 17, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE EVAL IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STENT'S OUTER PLASTIC COATING THAT LOCKS INTO THE DEVICE WAS ALLEGEDLY SEPARATING. ACCORDING TO THE TECH, THE TRACKING ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND WAS A STRAIGHT SHOT. A 9 F SHEATH AND 0.035 WIRE WERE USED FOR THE PROCEDURE. THE PHYSICIAN HAD DEPLOYED THE STENT NEARLY HALF WAY, WHEN THE SEPARATION WAS NOTICED. HE REMOVED THE DEVICE AND USED A DIFFERENT BRAND TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTECHNIK ANRF2860

    Patients

    Seq Age Sex Outcome Treatment
    1