BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1120068 · Received August 15, 2008

    Report

    Report Number
    9681442-2008-00126
    Event Type
    Malfunction
    Date Received
    August 15, 2008
    Report Date
    July 18, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTECHNIK KG
    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 ATTN TO THE MFG AND INSPECTION OF THIS PROD AND THE PROD WAS FOUND TO HAVE MET ALL SPECS PRIOR TO SHIPMENT. THE SAMPLE WAS DISCARDED BY THE USER FACILITY. THE RESULT OF THE EVAL IS 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 PROD STATES THAT THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYS HAS NOT BEEN ESTIMATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ALLEGEDLY A TRACHEOBRONCHIAL STENT GRAFT DID NOT DEPLOY. THE PHYSICIAN USED THE BASILIC VEIN AS THE SHEATHLESS APPROACH TO THE CEPHALIC VEIN. HE USED A .035 WIRE WITHOUT INCIDENT, AS THE TRACKING ANATOMY WAS NOT TORTUOUS OR CALCIFIED AND HE DID NOT MEET WITH RESISTANCE WHILE TRACKING TO THE TARGET LESION. HE WAS NOT ABLE TO DEPLOY THE STENT, ONCE IN PLACE AT THE INTENDED SITE. WHEN THE DEVICE WAS REMOVED, THE CATHETER SHOWED SIGNS OF STRESS AT THE POINT OF CONNECTION WITH THE TUOHY. HE USED ANOTHER TRACHEOBRONCHIAL STENT GRAFT, SAME SIZE, FOR A SUCCESSFUL PROCEDURE AND WITHOUT 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. MEDIZINTECHNIK KG ANRC1909

    Patients

    Seq Age Sex Outcome Treatment
    1