BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 15455337 · Received September 20, 2022

    Report

    Report Number
    3001845648-2022-00652
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    March 16, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    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 COULD NOT BE COMPLETED AS THE DEVICE OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE TO CAPTURE 1 CASE OF CHOLECYSTITIS IN THE METAL STENT GROUP( REF ATT. KOBAYASHI 2021). THE FOLLOWING FILES WERE ALSO RAISED FROM THIS JOURNAL ARTICLE: PR (B)(4) - KOBAYASHI ¿ ¿STENT OCCLUSION (PS GROUP)¿. PR (B)(4) - KOBAYASHI ¿ ¿SECONDARY OUTCOMES (PS GROUP)". PR (B)(4) - KOBAYASHI ¿ ¿SECONDARY OUTCOMES (MS GROUP)". PR (B)(4) - KOBAYASHI ¿ ¿STENT MIGRATION (MS GROUP).¿ PR (B)(4) - KOBAYASHI ¿ ¿RE- INTERVENTIONAL DRAINAGE (MS GROUP).¿ 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. AS PER THE JAPANESE PACKAGING INSERT (C-ES1608Y02) WHICH ACCOMPANIES THIS DEVICE INFORMS THE USER THAT "POTENTIAL SIGNIFICANT ADVERSE EVENTS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: CHOLECYSTITIS AND CHOLANGITIS.¿ THE JAPANESE PACKAGING INSERT (C-ES1608Y02) SUPPLIED WITH THE DEVICE COMPLIES WITH MHLW LAW NO. 84 OF 2013 WHICH AVOIDS INCLUDING INFORMATION THAT IS NOT SPECIFIC TO THE MEDICAL DEVICE OR THAT WHICH IS BASIC KNOWLEDGE ALREADY UNDERSTOOD BY THE HEALTHCARE PROFESSIONAL, TO ENSURE TO ACCURATELY CONVEY ALL THE INFORMATION THAT IS IMPORTANT FOR THE USER. 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. CHOLECYSTITIS WOULD BE RELATED TO STENT OCCLUSION ESPECIALLY USING FULLY COVERED STENT. THE FULLY COVERED STENT COULD BLOCK THE CYSTIC DUCT AND LEAD TO CHOLECYSTITIS.¿¿ REF ATT ¿¿PR 375136_CLINICAL INPUT¿¿. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION AS PER PACKAGING INSERT, CHOLECYSTITIS IS LISTED AS A POTENTIAL SIGNIFICANT ADVERSE EVENT ASSOCIATED WITH ERCP. CONFIRMATION OF COMPLAINT. COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION. ACCORDING TO THE LITERATURE CHOLECYSTITIS WAS OBSERVED IN 1 PATIENT IN THE MS GROUP. CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. ACCORDING TO THE INITIAL REPORT, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. THE PATIENT WITH CHOLECYSTITIS IMPROVED WITH ANTIBIOTIC TREATMENT. INVESTIGATION FINDINGS CONCLUDE THAT THE CHOLECYSTITIS WOULD BE RELATED TO STENT OCCLUSION ESPECIALLY USING FULLY COVERED STENT. THE FULLY COVERED STENT COULD POSSIBLY BLOCK THE CYSTIC DUCT AND LEAD TO CHOLECYSTITIS. ANOTHER POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT CONDITION AS PER PACKAGING INSERT, CHOLECYSTITIS IS LISTED AS A POTENTIAL SIGNIFICANT ADVERSE EVENT ASSOCIATED WITH ERCP. 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. CHOLECYSTITIS (MS GROUP): THE PATIENT WITH CHOLECYSTITIS IMPROVED WITH ANTIBIOTIC TREATMENT.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 16MAR2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2694731 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