BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 735543 · Received July 13, 2006

    Report

    Report Number
    9681442-2006-00056
    Event Type
    Injury
    Date Received
    July 13, 2006
    Date of Event
    June 13, 2006
    Report Date
    June 13, 2006
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    H10. 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 STENT IS IN TRANSIT TO THE MANUFACTURING SITE AND WILL BE EVALUATED. THIS APPLICATION REPRESENTS AN OFF-LABEL USE FOR THIS DEVICE. THE FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT IS INDICATED FOR USE IN THE TREATMENT OF TRACHEOBRONCHIAL STRICTURES PRODUCED BY MALIGNANT NEOPLASMS OR IN BENIGN STRICTURES AFTER ALL ALTERNATIVE THERAPRIES HAVE BEEN EXHAUSTED. THE 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 AN UPPER ARM A/V FISTULA STENOSIS, THE STENT WAS BUMPED BY A BALLOON AND MIGRATED. A .035 WIRE WAS USED. THE DOCTOR PREDILATED WITH AN 8 X 4 OR 8 X 6 CONQUEST BALLOON. THE PROXIMAL END OF THE STENT DI NOT DEPLOY AND WAS COMPLETEDLY COLLAPSED. THE DOCTOR REMOVED THE DELIVERY SYSTEM. THERE WAS A TIGHT STRICTURE 1-2 CM FROM THE PROXIMAL END OF THE STENT. THE DISTAL END DEPLOYED FINE. REPORTEDLY, THE DOCTOR SAW ONE BLACK DOT ON THE PROXIMAL END OF THE STENT. THE DOCTOR WENT IN WITH A BALLOON AND ACCIDENTLY BUMPED THE STENT. THE STENT STARTED TO FLOAT UP THE AXILLAE. THE SCRUB TECH COMPRESSED THE AXILLAE AT THE CEPHALIC ARCH. THE DOCTOR OPENED THE AXILLARY VEIN AND DID A CUT DOWN INTO THE VESSEL. THE DOCTOR CUT THE FLUENCY LONGITUDINALLY AND USED A HEMOSTAT TO REMOVE THE FLUENCY FROM THE PT. THE DOCTOR CLOSED AND THEN WENT BACK INTO THE PATIENT AND DELPOYED A VIA BOND (GORE) 9 MM. THE PATIENT IS CURRENTLY FINE. THE STENT IS AVAILABLE. THE DELIVERY SYSTEM WAS DISCARDED BY THE FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE * ANQC3629

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention