BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 10433476 · Received August 20, 2020

    Report

    Report Number
    3001845648-2020-00514
    Event Type
    Injury
    Date Received
    August 20, 2020
    Date of Event
    January 10, 2020
    Report Date
    February 14, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163468. DEVICE EVALUATION: THE COLONIC DEVICES INVOLVED IN THIS COMPLAINT WAS NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. COMPLAINT FILES PR (B)(4)(3001845648-2020-00513) , PR (B)(4)(3001845648-2020-00514) AND PR (B)(4)(3001845648-2020-00515) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4)(3001845648-2020-00514) WAS OPENED TO INVESTIGATE HEMATOCHEZIA 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 COLONIC DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. AS THE EVO COLONIC DEVICES FROM UNKNOWN LOT NUMBER, A REVIEW OF THE RELEVANT MANUFACTURING RECORDS CANNOT BE CONDUCTED. AS PER THE INSTRUCTIONS FOR USE, IFU0052-11, WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "INTESTINAL PERFORATION, ULCERATIONS". 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 ACUTE COLONIC OBSTRUCTION. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT OBTAINED SYMPTOM RELIEF AFTER CONSERVATIVE THERAPY. 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 THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    510(K) NUMBER: K163468 INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 1

    AS PER PAPER - "AFTER STENT INSERTION, ONE PATIENT SUFFERED FROM HEMATOCHEZIA. FENG ET AL 2020 ¿ ENDOSCOPIC SELF-EXPANDABLE METALLIC STENT INSERTION WITHOUT FLUOROSCOPIC GUIDANCE IS FEASIBLE AND SAFE FOR ACUTE COLONIC OBSTRUCTION CAUSED BY COLORECTAL CANCER THE OBJECTIVE OF THIS STUDY WAS TO EVALUATE THE EFFICACY AND FEASIBILITY OF THIS TECHNIQUE USING SEMS INSERTION. FROM JANUARY 2016 TO DECEMBER 2018, 36 PATIENTS WITH CRC OBSTRUCTION UNDERWENT ENDOSCOPIC SEMS INSERTION IN OUR CENTER. THE WHOLE STENTING PROCEDURE WAS MONITORED UNDER ENDOSCOPIC GUIDANCE ONLY. A THROUGH-THE-SCOPE TECHNIQUE WAS USED FOR ALL STENT INSERTIONS. A NITI-S UNCOVERED COLORECTAL STENT WITH A DIAMETER OF 22¿25MM AND A LENGTH OF 100MM FROM MICROTECH (NANJING, CHINA) OR COOK MEDICAL EVOLUTION(BLOOMINGTON,IN,USA) WAS USED ACCORDING TO THE ENDOSCOPIST¿S PREFERENCE. BRIEFLY, WHEN THE COLONOSCOPE REACHED THE OBSTRUCTION, A SPHINCTEROTOME (MICROTECH, NANJING, CHINA) FOR ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH A 0.035-INCH GUIDEWIRE (MICRO-TECH, NANJING, CHINA) OR JAGWIRE (BOSTON SCIENTIFIC, NATICK, MA, USA) WAS INTRODUCED. THE GUIDEWIRE WAS INSERTED TO TRAVERSE THE STRICTURE. THE GUIDEWIRE WAS INSERTED FOR APPROXIMATELY 40 CM, THEN PULLED BACKWARD AT APPROXIMATELY 10 CM, FOLLOWED BY AN ADDITIONAL INSERTION FOR APPROXIMATELY 20 CM. SUCCESSFUL GUIDEWIRE INSERTION WAS JUDGED BY A SMOOTH PASSAGE OF THE GUIDEWIRE WITHOUT ANY RESISTANCE. THE SPHINCTEROTOME WAS THEN INSERTED ALONG THE GUIDEWIRE TO CONFIRM THE PASSAGE OF THE OBSTRUCTION. THE DELIVERY SYSTEM WAS ADVANCED OVER THE GUIDEWIRE AND WAS GUIDED INTO THE SITE OF OBSTRUCTION UNTIL THE DISTAL END OF THE STENT WAS APPROXIMATELY 2CM AT THE EDGE OF THE TUMOR. IN THE STENT DEPLOYMENT PROCEDURE, THE DISTAL END OF THE STENT WAS KEPT 2CM BEYOND THE DISTAL EDGE OF THE LESION, WHILE THE OUTER SHEATH WAS RETRACTED. THE WHOLE PROCEDURE WAS MONITORED BY THE COLONOSCOPIC GUIDANCE ONLY. AFTER STENT INSERTION, ONE PATIENT SUFFERED FROM HEMATOCHEZIA. ALL PATIENTS OBTAINED SYMPTOM RELIEF AFTER CONSERVATIVE THERAPY. THE EXACT RPN UNKNOWN, 3 POSSIBLE RPNS: EVO-25-30-6-C EVO-25-30-8-C EVO-25-30-10-C IT CANNOT BE CONFIRMED OF THE OVERALL 36 STENTS PLACED, WHICH WERE COOK STENTS, THIS FILE IS CREATED TO CAPTURE THE POTENTIAL THAT IT COULD HAVE BEEN A COOK EVOLUTION STENT. THIS FILE WAS CREATED TO CAPTURE THE CASE OF HEMATOCHEZIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    893851 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention