BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1013261 · Received March 14, 2008

    Report

    Report Number
    9681442-2008-00028
    Event Type
    Malfunction
    Date Received
    March 14, 2008
    Report Date
    February 19, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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 NOT BEEN RETURNED FOR EVAL TO DATE. BASED ON THE INFO RECEIVED, THE RESULTS OF THE INVESTIGATION ARE INCONCLUSIVE AND THE ROOT CAUSE IS UNK. 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 DURING A PROCEDURE TO PLACE A STENT GRAFT IN THE PROXIMAL SFA, THE CATHETER BROKE AT THE TUOHY. THE PROCEDURE WAS FOR A LESION AT THE PROXIMAL SFA, AND THE APPROACH TAKEN WAS CONTRALATERAL FROM THE COMMON FEMORAL ARTERY. AN 8 F CROSSOVER SHEATH AND A 0.035 GUIDE WIRE WERE USED FOR THE PROCEDURE. THERE WAS NO DIFFICULTY ADVANCING TO THE LESION, EXCEPT AT THE BIFURCATION WHICH WAS TIGHT. ONCE THE DOCTOR WAS AT THE INTENDED SITE AND TRIED TO DEPLOY THE STENT GRAFT. THE CATHETER THEN BROKE AT THE TUOHY. THE SYSTEM WAS REMOVED AND THE PROCEDURE WAS COMPLETED WITHOUT DIFFICULTY, WITH ANOTHER STENT GRAFT. NO REPORTED INJURY TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRJ0157

    Patients

    Seq Age Sex Outcome Treatment
    1