BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 15455306 · Received September 20, 2022

    Report

    Report Number
    3001845648-2022-00653
    Event Type
    Injury
    Date Received
    September 20, 2022
    Report Date
    March 7, 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 FOR THE 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, WHICH ACCOMPANIES THIS DEVICE, INSTRUCTS THE USER THAT ¿¿ POTENTIAL COMPLICATIONS ASSOCIATED WITH ERCP INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, ASPIRATION, PERFORATION, HAEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRACT OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARRENT, CARDIAC ARRYTHMIA OR ARREST. 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 HOWEVER A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS. THE INSTRUCTIONS FOR USE LISTS CHOLANGITIS AND INFECTION WHICH COVERS LIVER ABSCESS AS A POTENTIAL COMPLICATIONS. CONFIRMATION OF COMPLAINT: COMPLAINT IS CONFIRMED BASED ON CUSTOMER AND/OR REP TESTIMONY. SUMMARY OF INVESTIGATION: ACCORDING TO THE LITERATURE THE SECONDARY OUTCOMES WERE RATES OF EBD-ASSOCIATED AND POSTOPERATIVE COMPLICATIONS. LIVER ABSCESS + CHOLANGITIS (N=1). CONFIRMED QUANTITY OF 1 DEVICE, CONFIRMED USED. THE PATIENT¿S OUTCOME IS UNKNOWN. INVESTIGATION FINDINGS CONCLUDE THAT A POSSIBLE ROOT CAUSE CAN BE ATTRIBUTED TO KNOWN POTENTIAL COMPLICATIONS. THE INSTRUCTIONS FOR USE LISTS CHOLANGITIS AND INFECTION AS A POTENTIAL COMPLICATION. 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. THE SECONDARY OUTCOMES (MS GROUP) WERE RATES OF EBD-ASSOCIATED AND POSTOPERATIVE COMPLICATIONS. LIVER ABSCESS + CHOLANGITIS (N=1).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 07-MAR-2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2698843 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