BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7153794 · Received December 29, 2017

    Report

    Report Number
    3001845648-2017-00610
    Event Type
    Malfunction
    Date Received
    December 29, 2017
    Date of Event
    December 7, 2017
    Report Date
    December 29, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # "K101530 AND K163468". 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. INVESTIGATION PENDING, A FOLLOW UP MDR WILL BE SUBMITTED WITH THE INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". AFTER THE DOCTOR PLACE THE WHOLE SYSTEM INTO THE DUODENAL , THEY TRY TO WITHDRAW THE STENT FROM THE HANDLE, BUT THEY HEAR A SOUND FROM THE HANDLE THEN THEY CANNOT WITHDRAW THE STENT, SO THEY USE ANOTHER NEW DEVICE

    Additional Manufacturer Narrative · 1

    PMA/510(K) # "K101530 AND K163468". (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). PROBLEM STATEMENT: THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: ¿AFTER A SOUND FROM THE HANDLE THEN PHYSICIAN CANNOT WITHDRAW THE STENT¿ ¿AFTER THE DOCTOR PLACE THE WHOLE SYSTEM INTO THE DUODENAL, THEY TRY TO WITHDRAW THE STENT FROM THE HANDLE, BUT THEY HEAR A SOUND FROM THE HANDLE THEN THEY CANNOT WITHDRAW THE STENT, SO THEY USE ANOTHER NEW DEVICE.¿ DEVICE EVALUATION: THE EVO-22-27-9-D DEVICE OF LOT NUMBER C1213228 WAS RETURNED TO COOK IRELAND AND EVALUATED ON THE 08-DEC-2018. LAB EVALUATION: UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS NO STENT EXPOSURE. NO LOCK WIRE WAS RETURNED. THE RED SHUTTLE DEPLOYMENT MARKER WAS AT THE BACK OF THE HANDLE. ACTUATION FOR DEPLOYMENT OR RETRACTION WAS NOT POSSIBLE. THE HANDLE OF THE DEVICE WAS DISMANTLED DURING LAB EVALUATION AND THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED DURING LAB EVALUATION WITH NO DIFFICULTY AND THE STENT WAS SEEN TO BE FINE. THE CUSTOMER COMPLAINT CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING LAB EVALUATION. IT MAY BE NOTED THAT THE FOLLOWING ADDITIONAL INFORMATION WAS ALSO RECEIVED FROM THE COOK REPRESENTATIVE: " WAS THE DELIVERY SYSTEM REMOVED WITH THE STENT PARTIALLY DEPLOYED? NO. WAS THE DIRECTIONAL BUTTON FULLY ENGAGED DURING DEPLOYMENT? YES. DID THE PATIENT REQUIRE ANY ADDITIONAL PROCEDURES OR INTERVENTION DUE TO THIS INCIDENT? NO". ROOT CAUSE: A POSSIBLE CAUSE FOR THE ISSUE OCCURRING MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH. DOCUMENTS REVIEW: PRIOR TO DISTRIBUTION ALL EVO-22-27-9-D 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 QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. AS PER FQC: ¿INSPECT FOR VISUAL DEFECTS; I.E. LOOSE OR EMBEDDED FOREIGN MATERIALS, ROUGH OR SHARP EDGES, KINKS.¿ ¿ENSURE THAT THERE ARE NO SHARP EDGES OR DAMAGE TO THE SHEATH TIP AREA." IFU REVIEW: AS PER 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 EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. SUMMARY: CUSTOMER COMPLAINT CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING LAB EVALUATION. 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 · 1

    FOLLOW UP MDR IS BEING SUBMITTED TO UPDATE THE INVESTIGATION CONCLUSIONS. MDR SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/ STRETCHED/ BROKE/ COMPRESSED". AFTER THE DOCTOR PLACE THE WHOLE SYSTEM INTO THE DUODENAL , THEY TRY TO WITHDRAW THE STENT FROM THE HANDLE, BUT THEY HEAR A SOUND FROM THE HANDLE THEN THEY CANNOT WITHDRAW THE STENT, SO THEY USE ANOTHER NEW DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934299 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR