BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11345444 · Received February 18, 2021

    Report

    Report Number
    3001845648-2021-00136
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    October 5, 2020
    Report Date
    July 29, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    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. THIS FILE WAS CREATED FROM THE ATTACHED JOURNAL ARTICLE. REFERENCE "(B)(4)." THIS FILE WAS OPENED TO INVESTIGATE PERFORATION AND INTERVENTION. LAB EVALUATION: 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. THESE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL. (D00059776 (QSI0975) REV 031, D00052106 (PRD0281) REV 015, D00055312 (FQC0172)REV 015). 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 "ADDITIONAL CONTRAINDICATIONS INCLUDE, BUT ARE NOT LIMITED TO : "SUSPECTED OR IMPENDING PERFORATION, INTRA-ABDOMINAL ABSCESS/PERFORATION.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. IMAGE REVIEW: N/A. 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 PATIENT HAD MALIGNANT COLORECTAL CANCER. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. 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 TO THE COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ZHOU-2020 (EVO-C): SAFETY AND EFFICACY OF THROUGH-THE-SCOPE PLACEMENT OF COLONIC SELF-EXPANDABLE METAL STENTS WITHOUT FLUOROSCOPIC GUIDANCE: A RETROSPECTIVE COHORT STUDY. RETROSPECTIVE STUDY CARRIED OUT IN PATIENTS UNDERGOING ENDOSCOPIC SEMS INSERTION WITH OR WITHOUT FLUOROSCOPIC GUIDANCE FOR MALIGNANT LARGE-BOWEL OBSTRUCTION IN A SINGLE TERTIARY MEDICAL CENTER. SEMS PLACEMENT WAS PERFORMED USING A 1-CHANNEL ENDOSCOPE WITH WORKING CHANNEL = 3.7 MM DIAMETER (CF-H260; OLYMPUS CO.,(B)(4)). THE STENTING PROCEDURES ARE BRIEFLY SUMMARIZED AS FOLLOWS: IN THE F GROUP, A HYDROPHILIC GUIDEWIRE AND A BILIARY DILATION CATHETER (COOK MEDICAL, (B)(4)) WERE INSERTED THROUGH THE STRICTURE. THEN, THE GUIDEWIRE WAS REMOVED AND A WATER-SOLUBLE CONTRAST AGENT WAS INJECTED THROUGH CATHETER TO INSURE PROPER ENTRY INTO THE PROXIMAL LUMEN AND TO EVALUATE THE LENGTH OF THE STENOSIS UNDER FLUOROSCOPY. THEN, AFTER THE GUIDEWIRE WAS REINSERTED AND THE DILATION CATHETER WAS WITHDRAWN, THE STENT WAS ADVANCED THROUGH THE ENDOSCOPE ACROSS THE LESION AND DEPLOYED UNDER ENDOSCOPIC AND FLUOROSCOPIC GUIDANCE. IN THE NF GROUP, PROCEDURES WERE OTHERWISE THE SAME AS IN F GROUP, EXCEPT THAT FLUOROSCOPY WAS NOT USED AND CONTRAST AGENT INJECTION WAS OMITTED (OFF-LABEL USE). GUIDEWIRE AND DILATION CATHETER WERE CONSIDERED ACROSS THE STRICTURE WHEN THEY WERE EASILY ADVANCED WITHOUT RESISTANCE. WHEN RESISTANCE WAS FELT, THE GUIDEWIRE TIP DIRECTION WAS ADJUSTED. INSERTION WAS RETRIED UNTIL EASY ADVANCE OF AT LEAST 10 CM OF BOTH THE GUIDEWIRE AND THE CATHETER. THE STENT WAS DEPLOYED ONLY UNDER ENDOSCOPIC MONITORING. STENT LENGTH MUST ALLOW FOR AT LEAST 2 CM OF ADDITIONAL EXPOSURE TO EACH END OF THE STRICTURE. IF ONE STENT WAS NOT LONG ENOUGH TO COVER THE OBSTRUCTION, A SECOND STENT WAS USED AND AT LEAST 3 CM OF OVERLAP WAS OBTAINED. 1 PATIENT IN THE FLUOROSCOPY GROUP EXPERIENCED PERFORATION. PERFORATION OCCURRED WITHIN 24 HOURS AFTER ENDOSCOPIC DILATION WHEN CLINICAL SUCCESS WAS NOT ACHIEVED AND AN EXPERT ENDOSCOPIST PERFORMED AN INTRASTENT DILATION. THE PATIENT UNDERWENT EMERGENT SURGERY WITH PERMANENT STOMA CREATION. NO PATIENT DIED OF ADVERSE EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241006 EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Required Intervention