BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 12047450 · Received June 23, 2021

    Report

    Report Number
    3001845648-2021-00513
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    March 8, 2021
    Report Date
    February 23, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED DEVICES INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE REFERENCE "TAKEDA#1-2020" COMPLAINT FILES PR (B)(4)(3001845648-2021-00511), (B)(4)(3001845648-2021-00512) , (B)(4)(3001845648-2021-00513), (B)(4)(3001845648-2021-00492) AND (B)(4)(1037905-2021-00505) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4)(3001845648-2021-00513) WAS OPENED TO INVESTIGATE PANCREATITIS. DOCUMENTS REVIEW INCLUDING IFU REVIEW: AS THE RPN AND LOT NUMBER OF THE COMPLAINT STENTS ARE UNKNOWN, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. HOWEVER, PRIOR TO DISTRIBUTION EVO BILIARY FULLY COVERED DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE EVO BILIARY DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. AS PER THE INSTRUCTIONS FOR USE, IFU0062-5, WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE "POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED THE PATIENT¿S PRE-EXISTING CONDITION. FROM THE INFORMATION PROVIDED IT IS KNOWN THAT THE PATIENTS HAD BORDERLINE RESECTABLE (BR) PANCREATIC CANCER (PC). SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. PANCREATITIS REQUIRED REINTERVENTION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    TAKEDA ET AL 2020 (EVO-FC-B) ¿ ¿NOVEL RISK FACTORS FOR RECURRENT BILIARY OBSTRUCTION AND PANCREATITIS AFTER METALLIC STENT PLACEMENT IN PANCREATIC CANCER¿. EVOLUTION BILIARY CONTROLLED-RELEASE STENT¿ FULLY COVERED WAS CATEGORIZED AS HIGH AXIAL FORCE (AF) STENT AND THE OTHER THREE STENTS WERE CATEGORIZED AS LOW AF STENTS. ERCP WAS PERFORMED USING A THERAPEUTIC DUODENOSCOPE (JF260, TJF260; OLYMPUS MEDICAL SYSTEMS, TOKYO, JAPAN) UNDER MODERATE SEDATION WITH INTRAVENOUS PETHIDINE AND MIDAZOLAM. WE BASICALLY PERFORMED ENDOSCOPIC SPHINCTEROTOMY (EST) WITH A SMALL TO MODERATE-SIZED INCISION AND INSERTED AN ENDOSCOPIC NASOBILIARY DRAINAGE (ENBD) TUBE IN THE FIRST SESSION BECAUSE OF REASONS SUCH AS CHOLANGITIS AND UNDETERMINED BILIARY STRICTURE. AFTER JAUNDICE OR CHOLANGITIS SUBSIDED, WE THEN DEPLOYED A SEMS UNDER FLUOROSCOPIC GUIDANCE IN THE SECOND SESSION. 14 PATIENTS DEVELOPED PANCREATITIS (MILD 1, MODERATE 6, AND SEVERE 7). PANCREATITIS OCCURRED IN 10.4 % OF PATIENTS (14/135) AFTER SEMS PLACEMENT. NINE PATIENTS (6.7 %, 9/135) DEVELOPED PANCREATITIS ON THE FOLLOWING DAY. INTERESTINGLY, OF THE 14 PATIENTS, THREE (21.4 %, 3/14) DEVELOPED LATE-ONSET PANCREATITIS MORE THAN 30 DAYS (39 TO 118 DAYS) AFTER SEMS PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    945351 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention