BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FORMULA 418 BILLIARY STENT SYSTEM

    MDR report key: 1050310 · Received May 22, 2008

    Report

    Report Number
    1820334-2008-00261
    Event Type
    Injury
    Date Received
    May 22, 2008
    Date of Event
    April 21, 2008
    Report Date
    April 25, 2008
    Manufacturer
    COOK, INC.
    Product Code
    FGE
    PMA / PMN Number
    K052539
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: THE DEVICE REMAINS IMPLANTED. ONLY LOT NUMBER PROVIDED TO ASSIST IN THIS INVESTIGATION. THIS ITEM IS INSPECTED 100% TO ENSURE THE BALLOON PROPERLY INFLATES TO THE SPECIFIED PARAMETERS, REWRAPS PROPERLY WHEN NEGATIVE PRESSURE IS APPLIED, VISUALLY VERIFYING THE SHAFT MATERIAL IS FREE OF BENDS, KINKS AND OTHER SURFACE IMPERFECTIONS, ALONG WITH VERIFYING THE STENT HAS BEEN PROPERLY PLACED ON THE BALLOON AND THAT THE BALLOON HAS BEEN MOLDED AROUND THE ENDS OF THE STENT PRIOR TO TRANSPORT. BASED UPON THE INFO PROVIDED, IT APPEARS THE DEVICE WAS UTILIZED IN AN OFF LABEL APPLICATION. COOK'S INSTRUCTIONS FOR USE STATES THAT THE FORMULA 418 STENT IS INTENDED FOR USE IN PALLIATION OF NEOPLASM'S IN THE BILIARY TREE. THE PRODUCT IS INTENDED FOR USE BY THE PHYSICIANS TRAINED AND EXPERIENCED IN DIAGNOSTIC AND INTERVENTIONAL TECHNIQUES. STANDARD TECHNIQUES FOR PLACEMENT OF BILIARY DUCT ACCESS SHEATHS, GUIDING CATHETERS/INTRODUCERS AND WIRE GUIDES SHOULD BE EMPLOYED. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAVE NOT BEEN ESTABLISHED. A RISK ANALYSIS WAS PERFORMED AND CONCLUDED THAT NO FURTHER ACTION WAS REQUIRED AT THIS TIME. HOWEVER, WE WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    DURING PLACEMENT OF A FORMULA 418 STENT IN 2008 IN A FEMALE PT WITH A LESION AT THE OSTIUM OF THE RIGHT RENAL, THE PHYSICIAN ENCOUNTERED DIFFICULTIES. THE PHYSICIAN WAS USING A .018 WIRE WITH THE SHEATH. WHEN HE PLACED THE STENT OVER THE LESION, IT WAS ABOUT 1MM PAST THE AREA HE WANTED TO STENT AS HE PULLED THE DEVICE BACK, THE END OF THE STENT STRUTS LOOKED FLARED AND THEY GOT CAUGHT ON THE PLAQUE IN THE VESSEL CAUSING IT TO SLIDE OFF THE BALLOON. THE STENT WENT DOWN INTO THE RENAL VESSEL. THE PHYSICIAN COULD NOT GET A SNARE TO GO THROUGH THE LESION. HE THEN PLACED AN ADD'L FORMULA 418 STENT OVER THE LESION AND DEPLOYED IT PERFECTLY. HE THEN TOOK A C2 CATHETER AND SNARE DOWN TO CAPTURE THE OTHER STENT AND HE COULD NOT RETRIEVE IT. THE FLARED END OF THE STENT WOULD CATCH ON THE DEPLOYED STENT AND HE COULD NOT RETRIEVE IT. HE THEN PLACED THE STENT INTO AN INFERIOR RENAL ARTERY BRANCH. THE PT WAS DOING FINE AS OF THREE DAYS LATER. THE PHYSICIAN WILL DO ADD'L TESTS TO MAKE SURE THERE ARE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FORMULA 418 BILLIARY STENT SYSTEM FGE BILIARY STENT FGE COOK, INC. NA 1959989

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention