BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1033009 · Received April 22, 2008

    Report

    Report Number
    9681442-2008-00052
    Event Type
    Malfunction
    Date Received
    April 22, 2008
    Report Date
    March 28, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THE SAMPLE HAS BEEN RETURNED; HOWEVER, THE EVALUATION HAS NOT BEEN COMPLETED. BASED ON THE INFORMATION AVAILABLE TO DATE, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNKNOWN. THIS APPLICATION REPRESENTS AN OFF-LABEL USE. THE FLUENCY TRACHEOBRONCHIAL STENT GRAFT IS INDICATED FOR USE IN THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES AND HAS NEVER BEEN TESTED FOR AN APPLICATION AS DESCRIBED IN THIS CASE. THE CURRENT IFU SUPPLIED WITH THIS PRODUCT STATES THAT THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAS NOT BEEN ESTABLISHED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AFTER A SUBCLAVIAN ANGIOPLASTY, THE DOCTOR WAS TRYING TO PLACE A STENT GRAFT, BUT THE GUIDE WIRE KINKED, PREVENTING THE DEPLOYMENT OF THE DEVICE. THE DOCTOR WAS ABLE TO GET PAST THE KINK, BUT THE STENT STILL FAILED TO DEPLOY. THE APPROACH TAKEN WAS THE BRACHIAL, USING A 0.035 GUIDE WIRE AND A 9F SHEATH. THE TRACKING TO THE INTENDED SITE WAS TORTUOUS AND THERE WAS CALCIFICATION IN THE VESSEL. THE DEVICE WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITH ANOTHER STENT GRAFT WITHOUT INCIDENT. NO REPORTED INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRG3124

    Patients

    Seq Age Sex Outcome Treatment
    1