BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 3022516 · Received March 20, 2013

    Report

    Report Number
    3001845648-2013-00029
    Event Type
    Injury
    Date Received
    March 20, 2013
    Date of Event
    February 22, 2013
    Report Date
    February 22, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K896323
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL INFORMATION PROVIDED CONFIRMED THE DEVICE INVOLVED IN THIS COMPLAINT TO BE A (B)(4) (CLSO) DEVICE. THE LOT NUMBER WAS NOT PROVIDED, THEREFORE IT WAS NOT POSSIBLE TO CHECK IF ANY OF THE AFFECTED LOT REMAINED IN STOCK. THE CUSTOMER CONFIRMED THE COMPLAINT DESCRIPTION AS FOLLOWS: "AFTER THE STENT IS PLACED, THE DOCTOR WAS AWARE OF THE FACT THAT THIS TYPE OF STENTS WILL BOUND BACK INTO THE DUODENUM. HE HAD EXPERIENCED THIS SEVERAL TIMES, HE SAID. IN THIS CASE THE STENT ALSO BOUND BACK AND DIDN'T STAY IN PLACE. HE REMOVED THE PLASTIC STENT (CLSO) AND PLACED TWO METAL STENTS..." FURTHER INFORMATION WAS RECEIVED AS FOLLOWS: "AFTER PLACEMENT IT'S MIGRATES SOME CENTIMETERS INTO THE DUODENUM; NOT THE HOLD STENT, SOME CENTIMETERS. THAN THE HIGH STENOSIS IS NOT COVERED ANYMORE AND THE DISTAL END OF THE STENT CAN PERFORATE THE DUODENUM. MIGRATION HAPPENED ALSO AFTER THE STENT IS HOLD IN SITU (FOR WARMING THE STENT TO BODY TEMPURA) WITH THE PUSHING CATHETER FOR MINUTES. THE DOCTOR BLAMED THE CURVED SHAPE OF THE STENT FOR THIS. IT ONLY HAPPENED WITH STENTING THE LIVER DUCTS AND THE STENT MAKES PROXIMAL A CURVE TO FOLLOW THE ANATOMY OF THE DUCT INSIDE THE LIVER. THE HIGH STENOSIS AND THE CURVE IN THE LIVER GIVES PRESSURE ON THE STENT WITH THE RESULT IT WILL FOLLOWS THE EASY WAY. THE WAY BACKWARD INTO THE DUODENUM." THERE WERE NO REPORTED ADVERSE EFFECTS TO THE PT AS A RESULT OF THIS COMPLAINT. THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT RETURNED FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. INFORMATION RECEIVED IN RELATION TO THIS COMPLAINT STATED "IT ONLY HAPPENED WITH STENTING THE LIVER DUCTS AND THE STENT MAKES PROXIMAL A CURVE TO FOLLOW THE ANATOMY OF THE DUCT INSIDE THE LIVER." AS PER INSTRUCTIONS FOR USE, (B)(4): "THIS DEVICE IS USED TO DRAIN OBSTRUCTED BILIARY DUCTS". AS PER A PRECAUTION INCLUDED IN THE INSTRUCTIONS FOR USE FOR THIS DEVICE: "THE TAPERED TIP END OF THE STENT OR SIDE HOLES MUST BE POSITIONED IN THE COMMON BILE DUCT WHILE THE OTHER END REMAINS IN THE DUODENUM. THE LONGER FLAPS OF THE ST-2 BILIARY STENT SHOULD BE POSITIONED IN THE DUCT WHILE THE SHORTER FLAPS REMAIN IN THE DUODENUM." IT WAS DETERMINED THAT THE CLSO STENT INVOLVED IN THIS COMPLAINT WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTIONS FOR RUSE FOR THIS DEVICE. THIS CLSO DEVICE WAS DEEMED TO HAVE BEEN USED 'OFF LABEL'. THE CAUSE OF THIS COMPLAINT CAN BE ATTRIBUTED TO THE MISUSE OF THIS CLSO DEVICE. IT MAY BE NOTED THAT MIGRATION AND PERFORATION OF THE DUODENUM ARE STATED AS POTENTIAL COMPLICATIONS ASSOCIATED WITH THE PLACEMENT OF CLSO DEVICES. AS THE LOT NUMBER OF THE CLSO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT PROVIDED, IT WAS NOT POSSIBLE TO CONDUCT A REVIEW OF THE RELEVANT MANUFACTURING RECORDS. PRIOR TO DISTRIBUTION ALL CLSO DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. NO CORRECTIVE ACTION IS REQUIRED AS A RESULT OF THIS COMPLAINT. IT WAS DETERMINED THE CLSO DEVICE INVOLVED IN THIS COMPLAINT WAS NOT USED IN ACCORDANCE WITH THE INSTRUCTION FOR USE. THE TWO YEAR COMPLAINT HISTORY HAS BEEN REVIEWED AND THIS COMPLAINT FOR THIS SPECIFIC RPN REPRESENTS AN ISOLATED OCCURRENCE. COMPLAINTS OF THIS NATURE WILL BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    AFTER THE STENT IS PLACED, THE DOCTOR WAS AWARE OF THE FACT THAT THESE TYPE OF STENTS WILL BOUND BACK INTO THE DUODENUM. HE HAD EXPERIENCED THIS SEVERAL TIMES. IN THIS CASE THE STENT ALSO BOUND BACK AND DIDN'T STAY IN PLACE. HE REMOVED THE PLASTIC STENT (CLSO) AND PLACED TWO METAL STENTS INSTEAD. THE REP INVOLVED IN THIS COMPLAINT CONFIRMED THE COMPLAINT DESCRIPTION AS FOLLOWS: "AFTER PLACEMENT IT'S MIGRATES SOME CENTIMETERS INTO THE DUODENUM; NOT THE HOLE STENT, SOME CENTIMETERS. THAN THE HIGH STENOSIS IS NOT COVERED ANYMORE AND THE DISTAL END OF THE STENT CAN PERFORATE THE DUODENUM. MIGRATION HAPPENED ALSO AFTER THE STENT IS HOLD IN SITU (FOR WARMING THE STENT TO BODY TEMPURA) WITH THE PUSHING CATHETER FOR MINUTES. THE DOCTOR BLAME THE CURVED SHAPE OF THE STENT FOR THIS. IT ONLY HAPPENED WITH STENTING THE LIVER DUCTS AND THE STENT MAKES PROXIMAL A CURVE TO FOLLOW THE ANATOMY OF THE DUCT INSIDE THE LIVER. THE HIGH STENOSIS AND THE CURVE IN THE LIVER GIVES PRESSURE ON THE STENT WITH THE RESULT IT WILL FOLLOW THE EASY WAY. THE WAY BACKWARD INTO THE DUODENUM." NO ADVERSE EFFECTS TO THE PATIENT WERE REPORTED AS A RESULT OF THIS COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    114808 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention