BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11344799 · Received February 18, 2021

    Report

    Report Number
    3001845648-2021-00135
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    February 22, 2020
    Report Date
    November 2, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    510(K) NUMBER: K163468. DEVICE EVALUATION: THE COLONIC DEVICES INVOLVED IN THIS COMPLAINT WERE NOT RETURNED TO CIRL FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT BASED INVESTIGATION WILL BE COMPLETE. THIS FILE WAS CREATED FROM THE JOURNAL ARTICLE "LOVERO - 2020" COMPLAINT FILES (B)(4) (3001845648-2021-00129), (B)(4) (3001845648-2021-00123), (B)(4) (3001845648-2021-00127), AND (B)(4) (3001845648-2021-00135) WERE OPENED AS A RESULT OF THIS PAPER THIS FILE (B)(4) (3001845648-2021-00135) WAS OPENED TO INVESTIGATE OBSTRUCTION DUE TO TUMOUR INGROWTH. AS THE RPN AND LOT NUMBER OF THE COMPLAINT DEVICES 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 PER THE INSTRUCTIONS FOR USE, IFU0052-11, WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: TUMOUR INGROWTH OR OVERGROWTH". THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. 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 ACUTE OBSTRUCTIVE COLORECTAL CANCER. 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

    LOVERO-2020, EVO-C, ENDOSCOPIC STENTING FOR COLORECTAL CANCER OBSTRUCTION AS A BRIDGE TO SURGERY STRATEGY. IN AN 8-YEAR PERIOD, CONSECUTIVE PATIENTS WITH ACUTE LEFT-SIDED COLONIC OBSTRUCTION, DUE TO LOCALLY ADVANCED COLORECTAL CANCER, UNDERWENT SEMS IMPLANTATION. AFTER THE STENTING, ALL PATIENTS UNDERWENT SURGERY AS AN ELECTIVE PROCEDURE. THE TYPE OF SURGERY, WAS LEFT AT THE SURGEON'S PREFERENCE. OF THE 22 STENTS IMPLANTED, 2 WERE EVOLUTION COLONIC STENTS. COMPLICATIONS IN THE PATIENTS RECEIVING SEMS WERE: STENT OCCLUSION, PERFORATIONS, MIGRATION, OBSTRUCTION DUE TO CANCER INGROWTH. IN 1 PATIENT, EARLY SEMS OBSTRUCTION DUE TO CANCER INGROWTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241576 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention