BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 3142490 · Received May 8, 2013

    Report

    Report Number
    3001845648-2013-00039
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    March 31, 2013
    Report Date
    April 9, 2013
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    PMA / PMN Number
    K113510
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WAS NO EVO-25-30-8-C DEVICE OF LOT C838091 IN STOCK AT THE TIME OF THE INVESTIGATION. THE EVO-25-30-8-C DEVICE WAS NOT AVAILABLE TO BE RETURNED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE DEVICE HAS NOT BEEN RETURNED; THEREFORE THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. ADDITIONAL INFORMATION RECEIVED IS AS FOLLOWS: "WHEN WE TALK ABOUT A COLONIC STENT IT IS MORE PRECISE TO USE ORAL (CLOSEST TO THE MOUTH) AND ANAL (CLOSEST TO ANUS), INSTEAD OF PROXIMAL AND DISTAL. I DON'T HAVE AN UPDATE OF THE PATIENT TODAY BUT SHE WAS OPERATED ACUTE AND STENT WITH TUMOR WERE REMOVED. CHEMOTHERAPY AFTERWARDS AS STANDARD TREATMENT TO COLON CANCER." THREE IMAGES WERE PROVIDED. BASED ON THE REVIEWED IMAGES THE CUSTOMER COMPLAINT COULD NOT BE CONFIRMED. THE FOLLOWING STATEMENT WAS RECEIVED FROM THE PRODUCT MANAGEMENT. "DUE TO THE POOR QUALITY OF THE IMAGES IT IS HARD TO BE DEFINITIVE ABOUT THE PRESENCE OF A PERFORATION." PRIOR TO DISTRIBUTION EVOLUTION DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-25-30-8-C OF LOT C838091 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT. PERFORATION AND PAIN ARE KNOWN POTENTIAL ADVERSE EFFECTS AS PER INSTRUCTION FOR USE, IFU. FROM THE INFORMATION PROVIDED, "DEPLOYMENT OF THE STENT WAS DONE WITHOUT DIFFICULTIES." A TWO YEAR REVIEW OF THE COMPLAINTS HISTORY FOR EVO-25-30-8-C DEVICES REVEALED NO OTHER COMPLAINTS OF THIS NATURE FOR THIS RPN. THIS THEREFORE REPRESENTS AN ISOLATED OCCURRENCE FOR THIS RPN OVER THIS TIMEFRAME. NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    THE COMPLAINT INFORMATION STATED THAT USER OF THE DEVICE HAD THE FOLLOWING ISSUE: "THE COLONOSCOPE WAS PLACED JUST BELOW THE TUMOR. A STANDARD SOFT NITINOL GUIDEWIRE WAS PLACED THROUGH THE STRICTURED PART, AND THE LONG PART OF THE WIRE ORAL TO THE TUMOR WAS LEFT IN PLACE. AT A CERTAIN POINT THE DOCTOR WAS IN DOUBT IF THE WIRE WAS IN THE RIGHT POSITION INSIDE THE COLON. THE DIRECTION OF WIRE INDICATED THOUGH THAT IT MUST BE THE COLON AND CONTRAST VERIFIED THE RIGHT POSITION. THE EVOLUTION COLONIC STENT WAS INTRODUCED OVER THE STANDARD 0.035 INCH GUIDEWIRE AND DEPLOYMENT OF THE STENT WAS DONE WITHOUT DIFFICULTIES. TEN DAYS AFTER THE PATIENT CAME BACK WITH PAIN IN THE STOMACH AND X-RAY SHOWED AIR IN THE PERITONEUM. ACUTE SURGERY WAS DONE AND THE SICK PART OF THE COLON WAS SURGICALLY REMOVED. IT WAS THEN NOTICED THAT THE ORAL PART OF THE EVOLUTION STENT CAUSED A PERFORATION."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202795 EVOLUTION COLONIC CONTROLLED-RELEASE STENT - UNCOVERED STENT, COLONIC METALIC EXPANDABLE MQR COOK IRELAND LTD C838091

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Hospitalization| R