BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11342937 · Received February 18, 2021

    Report

    Report Number
    3001845648-2021-00121
    Event Type
    Injury
    Date Received
    February 18, 2021
    Date of Event
    January 26, 2020
    Report Date
    August 26, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: 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). COMPLAINT FILES (B)(4) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE (B)(4) WAS OPENED TO INVESTIGATE OBSTRUCTION.. LAB EVALUATION: N/A. 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. 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 COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : TUMOR INGROWTH OR OVERGROWTH , STENT OCCLUSION ". 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 COLORECTAL CANCER. SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: 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 JOURNAL ARTICLE. "CAO-2020". COMPLAINT FILES PR (B)(4) AND PR (B)(4) (3001845648-2021-00122) WERE OPENED AS A RESULT OF THIS PAPER. THIS FILE PR 319986 (3001845648-2021-00121) WAS OPENED TO INVESTIGATE OBSTRUCTION. 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, WHICH ACCOMPANIES THIS DEVICE IT INFORMS THE USER ABOUT THE POTENTIAL COMPLICATIONS "ADDITIONAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO : TUMOR INGROWTH OR OVERGROWTH , STENT OCCLUSION ". 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 PATIENT HAD COLORECTAL CANCER. BASED ON MEDICAL ADVISOR OPINION, IT IS POSSIBLE THAT ITS DUE TO "CONDITIONS OCCURRING DURING DEVICE USE AND PRE-EXISTING CONDITIONS." SUMMARY: COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY. AS PER MEDICAL ADVISOR, PATIENT PATIENT OUTCOME WAS "REQUIRE HOSPITALISATION/PROLONG HOSPITALISATION" 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.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO A CORRECTIONS TO MULTIPLE FIELDS INCLUDING IMDFR CODES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    CAO-2020, EVO-C, COLON METAL STENTS AS A BRIDGE TO SURGERY HAD NO SIGNIFICANT EFFECTS ON THE PERINEURAL INVASION: A RETROSPECTIVE STUDY. STENT PLACEMENT WAS PERFORMED UNDER BOTH ENDOSCOPIC AND FLUOROSCOPIC GUIDANCE. THE MAIN TYPES OF COLON STENTS ARE WILSON COOK AND (B)(4) SCIENTIFIC. THE STENT SIZE AND LENGTH WERE CHOSEN ACCORDING TO THE MEASURED LENGTH OF THE OBSTRUCTION, AND UNCOVERED SEMS WAS USED AS A BRIDGE TO SURGERY. ONE PATIENT DEVELOPED AN OBSTRUCTION AGAIN AFTER STENT IMPLANTATION, AND STENT RE-INSERTION WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240257 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention