BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 15455334 · Received September 20, 2022

    Report

    Report Number
    3001845648-2022-00654
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    April 26, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION THE DEVICE EVALUATION FOR EVOLUTION BILIARY DEVICE OF UNKNOWN LOT COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. MANUFACTURING RECORDS: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. REVIEW HISTORICAL DATA: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. INSTRUCTIONS FOR USE AND/LABEL THE INSTRUCTIONS FOR USE, IFU0062 WHICH ACCOMPANIES THIS DEVICE, STATES '' ¿ADDITIONAL ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: ALLERGIC REACTION TO NICKEL , BILE DUCT ULCERATION , DEATH( OTHER THAN DUE TO NORMAL DISEASE PROGRESSION), FEVER, INFLAMMATION, INGROWTH DUE TO TUMOUR OR EXCESSIVE HYPERPLASTIC TISSUE , NAUSEA , OBSTRUCTION OF THE PANCREATIC DUCT , PAIN/DISCOMFORT , PERFORATION , RECURRENCE, OBSTRUCTIVE JAUNDICE, STENT MIGRATION , STENT MISPLACEMENT , STENT OCCLUSION , TRAUMA TO BILIARY TRACT OR DUODENUM, TUMOUR OVERGROWTH AND VOMITING.'' THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE ANALYSIS A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION RELATED, AS PER INSTRUCTIONS FOR USE, STENT MIGRATION IS LISTED AS AN ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT SUMMARY OF INVESTIGATION ACCORDING TO THE LITERATURE ONE COMPLICATION OF STENT MIGRATION OCCURRED. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT WITH THE STENT MIGRATION UNDERWENT RE- INTERVENTION DRAINAGE WITH NEW PLACEMENT OF FCSEMS TO RESTORE THE BILE FLOW. INVESTIGATION FINDINGS CONCLUDE A DEFINITIVE ROOT CAUSE WAS NOT ESTABLISHED. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO THE INSTRUCTIONS FOR USE, (IFU0062), STENT MIGRATION IS LISTED AS AN ADVERSE EVENTS THAT CAN OCCUR IN CONJUNCTION WITH BILIARY STENT PLACEMENT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    KOBAYASHI ET AL 2021 ¿COMPARISON OF PLASTIC STENT VERSUS METAL STENT IN PREOPERATIVE BILIARY DRAINAGE FOR PANCREATIC HEAD CANCER WITH NEOADJUVANT CHEMORADIOTHERAPY¿. IN THE PS GROUP, 7- FR, 7- CM STRAIGHT TYPE BILIARY STENTS (FLEXIMA; BOSTON SCIENTIFIC, NATICK, MA, USA) OR BOTH- END PIGTAIL- TYPE BILIARY STENTS (ZIMMON; COOK MEDICAL, BLOOMINGTON IN, USA) WERE USED WITHOUT ENDOSCOPIC SPHINC-TEROTOMY (EST). IN THE MS GROUP, 8- MM, 8- CM FULLY- COVERED SELF- EXPANDABLE METAL STENTS (FCSEMS, WALL FLEX; BOSTON SCIENTIFIC, BONASTENT; MEDICO¿S HIRATA OR EVOLUTION; COOK MEDICAL) WERE PLACED AFTER PERFORMING EST. THERE WERE 22 PATIENTS IN THE PS GROUP AND 21 PATIENTS IN THE MS GROUP. STENT MIGRATION (MS GROUP): THE PATIENT WITH THE STENT MIGRATION UNDERWENT RE- INTERVENTION WITH NEW PLACEMENT OF FCSEMS.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON THE 26-APR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694728 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 72 YR Male Required Intervention