BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY STENT

    MDR report key: 9738871 · Received February 21, 2020

    Report

    Report Number
    3001845648-2020-00114
    Event Type
    Malfunction
    Date Received
    February 21, 2020
    Date of Event
    August 14, 2016
    Report Date
    April 6, 2020
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    EXACT RPN AND LOT # UNKNOWN - MOST LIKELY US CLEARANCE NUMBER IS K121430. DEVICE EVALUATION: THE EVO (EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED) DEVICE OF UNKNOWN LOT NUMBER WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE OFF-LABEL USE, STENT PLACED IN A CREATED PROSTHETIC DUCT, NOT THE NATURAL BILIARY ANATOMY. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE EVO (EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED) DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. PRIOR TO DISTRIBUTION ALL EVO (EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED ) DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. THE INSTRUCTIONS FOR USE IFU0062-6 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "THIS DEVICE IS USED IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD BE DETERMINED FROM THE AVAILABLE INFORMATION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE USER USED THE DEVICE OFF-LABEL, AS THE STENT FOR MALIGNANT NEOPLASMS IN THE BILIARY TREE WAS PLACED IN A CREATED PROSTHETIC DUCT, THIS WOULD BE OFF-LABEL USE. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. ACCORDING TO THE INFORMATION REPORTED, ONE YEAR AFTER STENT REMOVAL, THE PATIENT WAS SYMPTOM-FREE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    GRACIENT A ET AL ¿¿RENDEZVOUS TECHNIQUE FOR TREATING BILIARY FISTULA¿. OFF LABEL USE: AN 8-CM BILIARY FULLY-COVERED SELF-EXPANDING METAL STENT WAS INSERTED, IN ORDER TO DECREASE PRESSURE ON THE BILIARY DUCT. IN ORDER TO AVOID MIGRATION, A 14-CM DUODENAL COVERED STENT (HANAROSTENT®, LIFE PARTNERS EUROPE, BAGNOLET, FRANCE) WAS POSITIONED NEXT TO THE BILIARY STENT¿S DISTAL PORTION. NEXT, A 12-CM, 8.5 FRENCH PLASTIC COTTON-LEUNG BILIARY STENT (COOK IRELAND LTD) WAS PLACED INTO THE COVERED SELF-EXPANDING METAL STENT THROUGH THE DUODENAL STENT (IN ORDER TO AVOID MIGRATION OF THE LATTER) AND LOCATED NEXT TO THE INLET OF THE EXTERNAL DRAIN. AFTER BILE FLOW THROUGH THE EXTERNAL DRAIN HAD FALLEN SIGNIFICANTLY (BY DAY 7 FOLLOWING THE COMBINED PROCEDURE), THE DRAIN WAS CLAMPED AND THEN REMOVED A FEW DAYS LATER. THE STENTS WERE REMOVED 45 D AFTER THEIR IMPLEMENTATION.

    Additional Manufacturer Narrative · 1

    EXACT RPN AND LOT # UNKNOWN - MOST LIKELY US CLEARANCE NUMBER IS K121430. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    GRACIENT A ET AL ¿¿RENDEZVOUS TECHNIQUE FOR TREATING BILIARY FISTULA¿. OFF LABEL USE: AN 8-CM BILIARY FULLY-COVERED SELF-EXPANDING METAL STENT WAS INSERTED, IN ORDER TO DECREASE PRESSURE ON THE BILIARY DUCT. IN ORDER TO AVOID MIGRATION, A 14-CM DUODENAL COVERED STENT (HANAROSTENT®, LIFE PARTNERS (B)(4)) WAS POSITIONED NEXT TO THE BILIARY STENT¿S DISTAL PORTION. NEXT, A 12-CM, 8.5 FRENCH PLASTIC COTTON-LEUNG BILIARY STENT (COOK (B)(4) LTD) WAS PLACED INTO THE COVERED SELF-EXPANDING METAL STENT THROUGH THE DUODENAL STENT (IN ORDER TO AVOID MIGRATION OF THE LATTER) AND LOCATED NEXT TO THE INLET OF THE EXTERNAL DRAIN. AFTER BILE FLOW THROUGH THE EXTERNAL DRAIN HAD FALLEN SIGNIFICANTLY (BY DAY 7 FOLLOWING THE COMBINED PROCEDURE), THE DRAIN WAS CLAMPED AND THEN REMOVED A FEW DAYS LATER. THE STENTS WERE REMOVED 45 D AFTER THEIR IMPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203799 BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR