BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6943394 · Received October 12, 2017

    Report

    Report Number
    3001845648-2017-00453
    Event Type
    Malfunction
    Date Received
    October 12, 2017
    Date of Event
    September 8, 2017
    Report Date
    November 8, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    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 WAS NOT LAUNCHED AS THE CABLE BROKE, PROBABLY DUE TO STRAINS ON THE ENDOSCOPE. ¿THEY HAD TO USE A SECOND STENT. DEVICE KEPT. PATIENT INJURY TO BE CONFIRMED. THEY WANT AN EXCHANGE." THE FOLLOWING INFORMATION WAS PROVIDED: ¿1) WAS THE STENT PARTIALLY DEPLOYED? NO. 2) DID THE PATIENT REQUIRE ANY INTERVENTION OR ADDITIONAL PROCEDURES? NO. 3) WAS THE CABLE HEARD BREAKING WITHIN THE HANDLE? YES PROBABLY. 4) CAN IT BE CONFIRMED IF THIS DEVICE IS RETURNING AND WHEN WE CAN EXPECT IT IF IT IS? THE DEVICE WAS KEPT BY HOSPITAL¿ FURTHER CLARIFICATION WHETHER THE DEVICE IS RETURNING HAS BEEN REQUESTED. IT IS UNKNOWN IF THE DEVICE INVOLVED IN THIS COMPLAINT WAS BEING RETURNED TO COOK IRELAND FOR EVALUATION; THE DEVICE HAS NOT YET BEEN RECEIVED, HOWEVER, IF IT IS RETURNED, THE DEVICE WILL BE EVALUATED AND THE INVESTIGATION WILL BE UPDATED. AS THE DEVICE WAS NOT RETURNED FOR EVALUATION; THE CAUSE OF THIS COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT THE FLEXOR MAY HAVE BROKEN A POSSIBLE CAUSE FOR WHICH MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH. 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 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 THIS EVO-22-27-9-D REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. 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 VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. 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 OF 'FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED' AS PER CUST: " STENT WAS NOT LAUNCHED AS THE CABLE BROKE, PROBABLY DUE TO STRAINS ON THE ENDOSCOPE. " AS PER COMPLAINT FORM "WHEN DOCTOR WANT TO RELEASE THE STENT IN THE DUODENUM, THE CABLE BROKE".

    Additional Manufacturer Narrative · 1

    PMA/510(K) # "K101530 AND K163468". (B)(4). EXEMPTION NUMBER: E2016031 IMPORTER SITE CONTACT AND ADDRESS: (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 1 X EVO-22-27-9-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 AND THE LOCKWIRE WAS IN PLACE. THE RED SHUTTLE DEPLOYMENT MARKER WAS HALF WAY BACK THE HANDLE. DEPLOYMENT OR RETRACTION WAS NOT POSSIBLE. THE HANDLE OF THE DEVICE WAS DISMANTLED DURING LAB EVALUATION TO SHOW THAT THE FLEXOR HAD BROKEN AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED AND NO ISSUES WERE NOTED WITH THE STENT. 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. AS USAGE CONDITION CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. A POSSIBLE CAUSE FOR THE ISSUE OCCURRING MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE TO DATE, ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET PROVIDED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    FOLLOW UP REPORT SUBMITTED DUE TO DEVICE RETURN AND EVALUATION. AS PER CUST: "STENT WAS NOT LAUNCHED AS THE CABLE BROKE, PROBABLY DUE TO STRAINS ON THE ENDOSCOPE." AS PER COMPLAINT FORM "WHEN DOCTOR WANT TO RELEASE THE STENT IN THE DUODENUM, THE CABLE BROKE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723283 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1