BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6313680 · Received February 9, 2017

    Report

    Report Number
    3001845648-2017-00041
    Event Type
    Injury
    Date Received
    February 9, 2017
    Date of Event
    January 12, 2017
    Report Date
    February 14, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    PMA / PMN Number
    K101530
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT IS CONSIDERED TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-22-27-9-D DEVICES ARE SUBJECTED TO 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 THIS EVOLUTION DEVICE OF LOT C1169388 DID NOT REVEAL ANY DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031. INFORMATION PERTAINING TO SECTION G.1 AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(4) COOK MEDICAL INCORPORATED (CMI) 1025 ACUFF ROAD P.O BOX 4195 BLOOMINGTON INDIANA 47402-4195. IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: 3005580113. IT WAS ORIGINALLY INDICATED THAT THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT BEING RETURNED TO COOK IRELAND FOR EVALUATION; HOWEVER THE DEVICE WAS RETURNED ON 07-FEB-2017. 1 X EVO-22-27-9-D DEVICE OF LOT NUMBER C1169388 WAS RETURNED FOR EVALUATION. IT WAS OBSERVED DURING THE DEVICE EVALUATION THAT THE LOCK WIRE HAD BEEN FULLY REMOVED AND WAS RETURNED WITH THE DEVICE. NO DAMAGE WAS EVIDENT ON THE LOCKWIRE. THERE WERE 2 KINKS EVIDENT ON THE POLYIMIDE. 1 PIECE OF WIRE FROM THE STENT WAS RETURNED. THE OD OF THE PIECE OF STENT WIRE WAS APPROXIMATELY 0.199MM. THE LENGTH OF THE PIECE OF STENT WIRE WAS APPROXIMATELY 18/19MM. THE CIRL R & D ENGINEER COMMENTED THAT IT IS ASSUMED THAT IT WAS THE PROXIMAL END OF THE STENT THAT BROKE. A DEFINITIVE CAUSE FOR THE REPORTED ISSUE WAS UNABLE TO BE DETERMINED AS THE ACTUAL USE CONDITIONS COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. THE CUSTOMER COMPLAINT WAS CONFIRMED AS A PIECE OF THE BROKEN STENT (STENT WIRE) WAS RETURNED CONCLUDING BREAKAGE OF THE STENT. PRIOR TO DISTRIBUTION ALL EVO-22-27-9-D DEVICES ARE SUBJECTED TO 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 THIS EVOLUTION DEVICE OF LOT C1169388 DID NOT REVEAL ANY DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "THE EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT WAS PLACED AND DEPLOYED CORRECTLY. WHEN THE CATHETER WAS BEING WITHDRAWN A SMALL PIECE OF WIRE HAD FALLEN OFF INSIDE THE PATIENT'S BOWEL, DUODENUM. USING FORCEPS, THE DOCTOR REMOVED THE WIRE. THE STENT WAS LEFT IN PLACE AND NO HARM WAS REPORTED TO THE PATIENT."

    Description of Event or Problem · 0

    AS REPORTED TO CUSTOMER RELATIONS: "THE EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT WAS PLACED AND DEPLOYED CORRECTLY. WHEN THE CATHETER WAS BEING WITHDRAWN A SMALL PIECE OF WIRE HAD FALLEN OFF INSIDE THE PATIENT'S BOWEL, DUODENUM. USING FORCEPS, THE DOCTOR REMOVED THE WIRE. THE STENT WAS LEFT IN PLACE AND NO HARM WAS REPORTED TO THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100553 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention