BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT

    MDR report key: 1062606 · Received June 18, 2008

    Report

    Report Number
    9681442-2008-00081
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 15, 2008
    Report Date
    May 29, 2008
    Manufacturer
    ANGIOMED GMBH & CO. MEDIZINTE
    Product Code
    JCT
    PMA / PMN Number
    K050832
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT HISTORY RECORDS HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MFG AND INSPECTION OF THIS PRODUCT AND THE PRODUCT WAS FOUND TO HAVE MET ALL SPECIFICATION PRIOR TO SHIPMENT. THE COMPLAINT IS INCONCLUSIVE, AS NO SAMPLE WAS RETURNED AS IT REMAINS IMPLANTED. NO SAMPLE EVALUATION COULD BE PERFORMED. NO IMAGES WERE AVAILABLE. NO ROOT CAUSE COULD BE DETERMINED FROM THE INFO RECEIVED. 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 THE PHYSICIAN WAS USING A STENT GRAFT TO COVER A PERFORATION (NOT CAUSED BY OUR PRODUCT). THE STENT GRAFT APPEARED TO HAVE A HOLE AND DID NOT STOP THE BLEEDING. HE THEN USED ANOTHER SIZE STENT GRAFT INSIDE THE FIRST ONE, AND THIS STOPPED THE BLEEDING. IT WAS REPORTED THAT THE TRACKING PATH WAS CALCIFIED, BUT THERE WERE NO OTHER STENTS TO GO THROUGH TO GET TO THE INTENDED SITE, THE ILIAC ARTERY. HE USED A FEMORAL UP AND OVER APPROACH. TRACKING PATH LENGTH IS UNK. NO INJURY WAS REPORTED, HOWEVER, THE PT HAD TO RECEIVED EXTRA UNITS OF BLOOD DUE TO THE EXTENDED LENGTH OF TIME NECESSARY TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT JCT ANGIOMED GMBH & CO. MEDIZINTE ANRB2835

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention