BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1024275 · Received March 27, 2008

    Report

    Report Number
    9681442-2008-00038
    Event Type
    Malfunction
    Date Received
    March 27, 2008
    Report Date
    February 28, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS RETURNED FOR EVALUATION. THE SAFETY CLIP AND THE 2-WAY STOP COCK WERE MISSING. THE TUOHY BORST ADAPTER WAS OPEN. THE STENT GRAFT WAS SHIFTED DISTAL BY 1 MM. THE OUTER SHEATH WAS TORN OFF AT THE CATHETER REINFORCEMENT AND ELONGATED IN THAT AREA. THE COMPLAINT IS CONFIRMED. THE CONDITION OF THE SAMPLE LEADS TO CONCLUDE THAT THE SYSTEM WAS EXPOSED TO HIGH FRICTION FORCES DURING ADVANCEMENT IN THE VESSEL, WHICH MAY HAVE RESULTED IN THE DESCRIBED DEPLOYMENT DIFFICULTIES, AND THE FRACTURE OF THE OUTER SHEATH. HOWEVER, BASED ON THE EVALUATION OF THE SAMPLE AND THE INFORMATION RECEIVED, THE EXACT ROOT CAUSE FOR THE DAMAGE TO THE PRODUCT COULD NOT BE DETERMINED. 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 AS THE DOCTOR ATTEMPTED TO DEPLOY, THE BLUE OUTER CATHETER BROKE JUST BEHIND THE HUB. THE INTENDED SITE WAS THE LEFT SFA AND THE APPROACH WAS A CONTRALATERAL APPROACH, FROM RIGHT TO LEFT. AN 8F CROSSOVER SHEATH AND A 0.035 STIFF GUIDE WIRE WERE USED FOR THE PROCEDURE. THE EXACT DISTANCE OF THE TRACKING PATH IS NOT KNOWN, HOWEVER, IT WAS ALMOST TO THE KNEE. THERE WAS SOME CALCIFICATION PRESENT WHICH REQUIRED PREDILATION. THERE WERE NO DIFFICULTIES OR RESISTANCE IN ADVANCING THE DELIVERY SYSTEM TO THE TARGET LESION. NO EXCESSIVE FORCE WAS USED. NO INJURY TO THE PT WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRH2599

    Patients

    Seq Age Sex Outcome Treatment
    1