BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 11997503 · Received June 15, 2021

    Report

    Report Number
    3001845648-2021-00495
    Event Type
    Injury
    Date Received
    June 15, 2021
    Date of Event
    May 14, 2021
    Report Date
    October 7, 2021
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480381
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    PMA/510(K) #: K163468. DEVICE EVALUATION: THE EVO-25-30-10-C DEVICE OF LOT NUMBER C1779448 INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION EVO-25-30-10-C 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 A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-25-30-10-C OF LOT NUMBER C1779448 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THE REVIEW OF RELEVANT MANUFACTURING RECORDS, CONFIRMS THE FAILURE MODE HAS NOT PREVIOUSLY OCCURRED WITH THE CURRENT LOT NUMBER. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER C1779448. IT SHOULD BE NOTED THAT THE INSTRUCTIONS FOR USE, IFU0052-11, STATES THE FOLLOWING: ¿IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE¿. THERE IS NOT SUFFICIENT EVIDENCE TO SUGGEST THE USER DID NOT FOLLOW THE IFU. IMAGE REVIEW: IMAGES WERE PROVIDED TO SUPPORT THE COMPLAINT INVESTIGATION. THEY WERE REVIEWED THROUGH COOK RESEARCH INC. (CRI) AND THE FOLLOWING COMMENTS WERE PROVIDED BY THE INDEPENDENT REVIEWER: 1. AN ABDOMINAL X-RAY REPORTEDLY PERFORMED THREE DAYS POST IMPLANTATION IS PROVIDED ALONG WITH THE COMPLAINT REPORT. 2. THE COMPLAINT CONCERNS A RETAINED PIECE OF THE DELIVERY SYSTEM AFTER DEPLOYMENT WITHOUT FLUOROSCOPY. 3. THE X-RAY WAS LIKELY TAKEN IN THE STANDARD AP PROJECTION. THE SHADOW IS ABSENT AND THE STOMACH BUBBLE PRESENT ON THE LEFT. 4. THE INNER CANNULAR FROM THE TIP TO PAST THE YELLOW MARKER WAS INSIDE THE DESCENDING COLON AND THE STENT. 5. THE STENT IS SLIGHTLY MORE DISTAL IN A LONG STENOSIS AT DESCENDING AND SIGMOID COLON JUNCTION. IMPRESSION: DELIVERY SYSTEM SEPARATION WITH RETENTION OF AN INNER CANNULA FRAGMENT IS CONFIRMED. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO TORTUROUS PATIENT ANATOMY. IT IS POSSIBLE THAT DURING DEPLOYMENT TORTUOUS PATH MAY HAVE CAUSED A BUILD-UP OF PRESSURE RESULTING IN THE INNER CATHETER BREAK. SUMMARY: COMPLAINT IS CONFIRMED AS THE FAILURE WAS VERIFIED IN THE IMAGE. DELIVERY SYSTEM SEPARATION WITH RETENTION OF AN INNER CANNULA FRAGMENT WAS CONFIRMED IN THE IMAGING REVIEW. A SECOND COLONOSCOPY TO EXTRACT THE PIECE OF CATHETER BROKEN AND LEFT INSIDE THE COLON WAS REQUIRED 3 DAYS AFTER THE INITIAL STENT WAS IMPLANTED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. NOTE THAT THIS FILE IS RELATED TO (B)(4) (EMDR 3001845648-2021-00770) (USER ERROR: DEPLOYMENT WITHOUT FLUOROSCOPY).

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE AN IMAGE REVIEW BEING RECEIVED. IMAGE REVIEW RECEIVED 13-AUG-21: "DELIVERY SYSTEM SEPARATION WITH RETENTION OF INNER CANNULA FRAGMENT IS CONFIRMED"

    Description of Event or Problem · 0

    FINAL MDR BEING SUBMITTED DUE TO COMPLETION OF THE INVESTIGATION ON 07-OCT-21.

    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

    THE INNER CATHETER SHOWS TO BE IN THE PATIENT AFTER 3 DAYS AFTER THE STENT WAS IMPLANTED. STENT PLACEMENT REQUIRED OF TWO RECAPTURES BEFORE THE FINAL STENT PLACEMENT (NO PROBLEMS); THEY PULLED OFF THE SECURITY WIRE GUIDE (NO PROBLEM). THE STENT WAS PERFECTLY PLACED AND IT BEGAN TO DRAIN ALL DEBRIS, NEVERTHELESS THEY ENDOSCOPICALLY SAW SOMETHING WEIRD BUT COULDN'T BE CLEARLY SEEN, TOO MUCH DEBRIS. NEXT MONDAY THEY MADE AN X-RAY AND THEY FOUND WHAT THEY SUPPOSEDLY SAW. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECOND COLONOSCOPY TO EXTRACT THE PIECE OF CATHETER BROKEN AND LEFT INSIDE THE COLON. PATIENT OUTCOME: A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. A SECOND COLONOSCOPY TO EXTRACT THE PIECE OF CATHETER BROKEN AND LEFT INSIDE THE COLON. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901811 EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48038 C1779448 10827002480381

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention