BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7361496 · Received March 22, 2018

    Report

    Report Number
    3001845648-2018-00136
    Event Type
    Malfunction
    Date Received
    March 22, 2018
    Date of Event
    February 21, 2018
    Report Date
    February 22, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MQR
    UDI-DI
    10827002480282
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ES
    Reporter Occupation
    OTHER

    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. DEVICE EVALUATION: THE EVO-25-30-8-C DEVICE OF LOT NUMBER C1415953 WAS NOT RETURNED TO COOK IRELAND FOR EVALUATION. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED IN THE COMPLAINT FILE: THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE WIRE GUIDE THROUGH THE STRICTURE. THERE WAS NO RESISTANCE ENCOUNTERED WHEN ADVANCING THE INTRODUCER AND STENT INTO POSITION. OLYMPUS COLONIC ENDOSCOPE OLYMPUS CFQ-160-L ENDOSCOPE WAS USED DURING THE PROCEDURE. DILATION OF THE STRICTURE HAD NOT BEEN PERFORMED PRIOR TO STENT PLACEMENT. NO SECTION OF THE DEVICE DETACH INSIDE THE PATIENT. IN ADDITION THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK REPRESENTATIVE: 1. WAS THE STENT DEPLOYED/ PARTIALLY DEPLOYED? NO. 2. DID THE PHYSICIAN HEAR ANY MECHANICAL SNAPPING, POPPING, OR GRINDING COMING FROM THE HANDLE? YES LITTLE. 3. DID THE PHYSICIAN NOTICE ANY DAMAGE TO THE DEVICE? NO, ALWAYS CHECK BEFORE USE. 4. WAS THERE ANY INTERVENTION OR ANY ADDITIONAL PROCEDURES?, NO, USE ANOTHER EVOLUTION COLONIC STENT. THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ENGINEERING INPUT WAS OBTAINED TO DETERMINE THE CAUSE OF THIS COMPLAINT, HOWEVER AS THE DEVICE WAS NOT RETURNED FOR INVESTIGATION A DEFINITE ROOT CAUSE COULD NOT BE DETERMINE. POSSIBLE CAUSE OF THIS EVENT COULD HAVE BEEN A KINK IN THE FLEXOR, RESULTING IN A BUILDUP OF PRESSURE AND THE FLEXOR BREAKING AT THE SHUTTLE CAP. KINK MAY HAVE BEEN PATIENT ANATOMY RELATED, I.E. TORTUROUS PATIENT ANATOMY, OR ON INSERTION INTO THE SCOPE. THIS WOULD ACCOUNT FOR THE USERS¿ INABILITY TO DEPLOY THE STENT. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL EVO-25-30-8-C DEVICES ARE SUBJECTED TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR THIS EVOLUTION DEVICE OF LOT C1415953 DID NOT SHOW ANY DISCREPANCIES IN THE MANUFACTURING RECORDS THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT # C1415953; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT # C1415953. IFU REVIEW: THE INSTRUCTIONS FOR USE WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF AN ABNORMALITY IS DETECTED THAT WOULD PROHIBIT PROPER WORKING CONDITION, DO NOT USE". ON REVIEW OF THE INFORMATION PROVIDED, THERE IS NO VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: THERE IS NO EVIDENCE TO SUGGEST THAT THIS EVENT DID NOT OCCUR, THEREFORE THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. 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. S.

    Description of Event or Problem · 0

    MALFUNCTION OF THE HANDLE, PROSTHESIS COULDN'T BE RELEASED. "AS PER COMPLAINT FORM": THE MOMENT TO OPERATE THE HANDLE TO RELEASE THE STENT THIS MADE NOISE, THE STENT WAS NOT RELEASED, REMAINED INSIDE THE CATHETER. THEY CHECKED THE RELEASE BUTTON AND IT WAS CORRECT. THEY PROCEEDED TO REMOVE THE SYSTEM AND USE A NEW ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    204602 EVOLUTION® COLONIC CONTROLLED-RELEASE STENT - UNCOVERED MQR STENT, COLONIC METALLIC EXPANDABLE MQR COOK IRELAND LTD G48028 10827002480282

    Patients

    Seq Age Sex Outcome Treatment
    1