BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5523038 · Received March 24, 2016

    Report

    Report Number
    3001845648-2016-00077
    Event Type
    Injury
    Date Received
    March 24, 2016
    Date of Event
    May 28, 2015
    Report Date
    March 1, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K)# OF SIMILAR DEVICE: K121430. THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVALUATION. THE STUDY SITE HAS INDICATED DISEASE PROGRESSION AND COMPLICATIONS OF THE PROCEDURE AS THE CAUSE OF THE PATIENTS DEATH. CLINICAL OPINION WAS RECEIVED IN RELATION TO THIS COMPLAINT: ¿I THINK I WOULD AGREE WITH WHAT THE DOCTOR INITIALLY STATED, THAT THE PATIENTS CO-MORBIDITIES CAUSED/CONTRIBUTED TO THE SEPSIS.¿ ALSO CIRL RESEARCH AND DEVELOPMENT ENGINEER PROVIDED COMMENTS ¿WHEN HE POSITIONED THE STENT DISTALLY, AND CORRECTLY POSITIONED THE STENT DISTAL END ACROSS THE PAPILLA, HE FOUND THAT THE PROXIMAL END OF THE STENT NO LONGER BRIDGED THE STRICTURE. THIS MEANT THAT THE DOCTOR HAD CHOSEN A STENT THAT WAS TOO SHORT AND THAT COULD NOT ACHIEVE THE DESIRED EFFECT.¿ AS PER THE INSTRUCTIONS FOR USE THE DEPLOYED STENT DISTAL REPOSITIONING SHOULD BE CARRIED OUT AS FOLLOWS: ¿TO REPOSITION DISTALLY/REMOVE STENT DURING INITIAL STENT PLACEMENT PROCEDURE, GRASP THE YELLOW GRASPING LOOP AT END OF STENT WITH FORCEPS (FIG. G) AND REPOSITION DISTALLY/REMOVE AS REQUIRED.¿ THE CUSTOMER COMPLAINT WAS NOT CONFIRMED AS THE INFORMATION PROVIDED STATED THAT DISEASE PROGRESSION AND COMPLICATIONS OF THE PROCEDURE AS THE CAUSE OF THE PATIENTS DEATH. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-FC-10-11-4-B DEVICE COULD NOT BE COMPLETED AS THE LOT NUMBER OF THE DEVICE WAS NOT PROVIDED. PRIOR TO DISTRIBUTION ALL EVO-FC-10-11-4-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    INVESTIGATIONAL STUDY #: (B)(4). EVOLUTION BILIARY STENT SYSTEM - FULLY COVERED; PATIENT #: (B)(6) - DIFFICULT REMOVAL. ON THE DAY OF THE PROCEDURE ((B)(6) 2015) THE BILIARY STRICTURE MEASURED 1.5 CM IN LENGTH AND WAS LOCATED IN THE COMMON BILE DUCT AT LEAST 2 CM BELOW THE HEPATIC BIFURCATION. WHEN ASKED IF THE STUDY STRICTURE WAS LOCATED BELOW THE CYSTIC DUCT THE SITE NOTED THE FOLLOWING: "THE CYSTIC DUCT IS NOT VISUALIZED." THE COMMON BILE DUCT WAS NOT CONSIDERED TORTUOUS. SPHINCTEROTOMY WAS PERFORMED AND A PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED. A 4 CM EVOLUTION BILIARY STENT-FULLY COVERED WAS INITIALLY PLACED (DIAMETER AND LOT NUMBER UNKNOWN). THE STENT WAS REMOVED AND THE SITE NOTED THE FOLLOWING, "STENT WAS TO SHORT WITH THE DISTAL END IN THE CBD (COMMON BILE DUCT)." REMOVAL OF THE STENT WAS CONSIDERED DIFFICULT AND THE SITE NOTED THE FOLLOWING, "A BILIARY PAPILLOTOMY WAS DONE TO MAKE IT EASIER TO MOBILIZE THE STENT. THE STENT WAS MOVED TO DISTAL, THE PROXIMAL END WAS NOW DISTAL FROM THE BEGINNING OF THE STENOSIS, THEREFORE THE ENTIRE STENT REMOVED." A 10 MM X 6 CM (B)(4) EVOLUTION BILIARY STENT-FULLY COVERED WAS THEN PLACED AT THE INTENDED LOCATION. THERE WAS NO PRE-STENT DILATION PERFORMED. DEPLOYMENT WAS CONSIDERED NEITHER EASY NOR DIFFICULT. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS VISUAL CONFIRMATION OF BILE FLOW. NO ADDITIONAL PROCEDURES WERE PERFORMED. THE SITE INDICATED THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF BOTH DEVICES. ADDITIONAL INFORMATION PER MONITOR EMAIL ENTERED INTO (B)(6) 3/4/2016: WITH REGARDS TO THE STENT REMOVAL, PROF. (B)(6) CONFIRMED THAT THERE WERE NO PROBLEMS WITH THE STENT ITSELF; THEY WERE SATISFIED WITH THE STENT. AS THE STENT WAS TOO SHORT IT WAS DIFFICULT TO REMOVE, SO THEY HAD TO DO SOME EXTRA PROCEDURES IN ORDER TO GET IT REMOVED. THEREFORE, THEY INDICATED IN THE EDC-SYSTEM THAT IT WAS HARD TO REMOVE THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    180395 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention