BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMON BILIARY STENT

    MDR report key: 15454847 · Received September 20, 2022

    Report

    Report Number
    3001845648-2022-00650
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    April 14, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    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 21X ZIMMON BILIARY STENT DEVICES OF UNKNOWN RPN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WERE NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. THIS FILE WAS CREATED IN RESPONSE TO THE JOURNAL ARTICLE ¿COMPARISON OF PLASTIC STENT VERSUS METAL STENT IN PREOPERATIVE BILIARY DRAINAGE FOR PANCREATIC HEAD CANCER WITH NEOADJUVANT CHEMORADIOTHERAPY¿ TO CAPTURE STENT OCCLUSION WITH ACUTE CHOLANGITIS. THE FOLLOWING FILES WERE ALSO RAISED FROM THIS JOURNAL ARTICLE: (B)(4) (3001845648-2022-00651) - KOBAYASHI ¿ ¿SECONDARY OUTCOMES (PS GROUP)." (B)(4) (3001845648-2022-00653) - KOBAYASHI ¿ ¿SECONDARY OUTCOMES (MS GROUP)." (B)(4) (3001845648-2022-00652)- KOBAYASHI ¿ ¿CHOLECYSTITIS (MS GROUP).¿ (B)(4) (3001845648-2022-00654) - KOBAYASHI ¿ ¿STENT MIGRATION (MS GROUP).¿ (B)(4) (3001845648-2022-00655)- KOBAYASHI ¿ ¿RE- INTERVENTIONAL DRAINAGE (MS GROUP).¿ LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: 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. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW: THE JAPANESE PACKAGING INSERT 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. CHOLANGITIS IS A KNOWN RISK ASSOCIATED WITH ERCP AS PER THE IFU: ¿THOSE ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ STENT OCCLUSION IS A KNOWN RISK ASSOCIATED WITH BILIARY STENT PLACEMENT AS PER MEDICAL ADVISORS¿ INPUT. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE OR PRODUCT LABEL. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER BOTH STENT OCCLUSION AND CHOLANGITIS ARE KNOWN RISKS ASSOCIATED WITH BILIARY STENT PLACEMENT AND ERCP RESPECTIVELY. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, STENT OCCLUSION WITH ACUTE CHOLANGITIS OCCURRED IN 21 OF 22 CASES. THOSE CASES WERE FORCED TO CHANGE THE NACRT SCHEDULE, BUT THE TIME TO SURGERY DID NOT CHANGE. FOR THESE 21 CASES, THE PLASTIC STENT WAS REMOVED AND A FCSEMS WAS PLACED AFTER PERFORMING EST. IT MAY BE THE CASE THE PATIENT COULD HAVE HAD AN INCREASED RISK OF STENT OBSTRUCTION AND SUBSEQUENT CHOLANGITIS DUE TO AN INCREASED RISK FOR BILIARY SLUDGE CAUSED BY SLOUGHING OF CELLULAR MATERIAL GENERATED AS A RESULT OF CHEMOTHERAPY. ANOTHER FACTOR COULD BE AN INCREASED BACTERIAL COLONIZATION OF THE STENT DUE TO IMMUNE COMPROMISE. 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 OCCLUSION: IN THE PS GROUP, STENT OCCLUSION WITH ACUTE CHOLANGITIS OCCURRED IN 21 OF 22 CASES. THOSE CASES WERE FORCED TO CHANGE THE NACRT SCHEDULE, BUT THE TIME TO SURGERY DID NOT CHANGE. THE MEDIAN TIME FROM INITIAL BILIARY DRAINAGE TO THE ONSET OF STENT TROUBLES IN PS WAS 18 DAYS (RANGE: 3- 49 DAYS). FOR THESE 21 CASES, PS WAS REMOVED, AND FCSEMS WAS PLACED AFTER PERFORMING EST. PS WAS REMOVED, AND FCSEMS WAS PLACED AFTER PERFORMING EST.

    Description of Event or Problem · 0

    THIS SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON THE 14-APR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2636376 ZIMMON BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Required Intervention