BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7133404 · Received December 20, 2017

    Report

    Report Number
    3001845648-2017-00620
    Event Type
    Malfunction
    Date Received
    December 20, 2017
    Date of Event
    November 15, 2017
    Report Date
    November 29, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    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. THE CUSTOMER REPORTED THE FOLLOWING COMPLAINT ISSUE: ¿STENT DIDN'T RELEASE FROM THE CARRIER SYSTEM. CONTACT IN DEPT IS DR. (B)(6)¿ THE FOLLOWING ADDITIONAL INFORMATION WAS PROVIDED: ¿YES IT WAS IN CONTACT WITH THE PATIENT 1) DID THE STENT PARTIALLY DEPLOY WITHIN THE PATIENT? NO. 2) WAS THERE ANY ISSUE NOTED WITH THE HANDLE OR SOUND WHEN THE STENT WAS DEPLOYING? NO. 3) DID THE PATIENT REQUIRE INTERVENTION OR ANY ADDITIONAL PROCEDURES? NO . THEY´VE NOTICED THE BREAK DURING THE RELEASE OF THE STENT. THE STRICTURE COULD BE PASSED WITHOUT ANY PROBLEM. OLYMPUS DUODENOSCOPE WITH SIDEVIEW OPTIC (190). THE STRICTURE WAS 7CM/ PYLORUS & DUODENUM. THERE WAS NO PROBLEME ADVANCING THE WIRE GUIDE. NO RESISTENCE NOTICED WITH THE PRODUCT.THE MARK WAS VISIBLE THE ENTIRE TIME. UNFORTUNATELY THE CUSTOMER CAN´T DELIVER ANY PICTURES¿ IT WAS CONFIRMED THAT THE PROCEDURE WAS FINISHED ¿WITH A NEW EVOLUTION FROM THE CONSIGNMENT.¿ 1 X EVO-22-27-12-D WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS NO STENT EXPOSURE FROM THE SHEATH ON RETURN OF THE DEVICE. THE LOCKWIRE WAS IN PLACE AND THE RED SHUTTLE DEPLOYMENT MARKER WAS TOWARDS THE BACK HALF OF THE HANDLE. THERE WAS DAMAGE NOTED TO THE INTRODUCER. THE FLEXOR WAS BROKEN AT THE COILED SECTION BEYOND THE TRANSITION OF THE BLUE AND CLEAR MATERIAL. THE DEVICE OPERATED CORRECTLY DURING LAB EVALUATION AND THE INNER CATHETER WAS WORKING CORRECTLY. ACTUATION WAS POSSIBLE UP TO THE POINT THAT THE FLEXOR WAS BROKEN. THE CUSTOMER COMPLAINT WAS CONFIRMED AS THE FAILURE WAS VERIFIED IN LAB; THE FLEXOR WAS BROKEN AT THE COILED SECTION. AS USAGE CONDITIONS CANNOT BE REPLICATED IN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE FOR THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE SIDE VIEWING SCOPE USED COULD HAVE CAUSED THE DAMAGE, THERE MAY HAVE BEEN EXCESSIVE USE OF THE ELEVATOR. A REVIEW OF THE QC RECORDS DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. PRIOR TO DISTRIBUTION ALL EVO-22-27-12-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 MANUFACTURING RECORDS FOR EVO-22-27-12-D OF LOT NUMBER DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE AFFECTS THE ENTIRE LOT #; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #. AS PER THE INSTRUCTIONS FOR USE, NOTES SECTION THE USER IS INSTRUCTED OF THE FOLLOWING: ¿VISUALLY INSPECT WITH PARTICULAR ATTENTION TO KINKS, BENDS AND BREAKS. IF ANY 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. FROM THE INFORMATION PROVIDED, 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.

    Description of Event or Problem · 0

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". STENT DIDN'T RELEASE FROM THE CARRIER SYSTEM. CONTACT IN DEPT IS DR. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    912860 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48027 10827002480275

    Patients

    Seq Age Sex Outcome Treatment
    1