BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7517498 · Received May 16, 2018

    Report

    Report Number
    3001845648-2018-00213
    Event Type
    Malfunction
    Date Received
    May 16, 2018
    Date of Event
    April 12, 2018
    Report Date
    May 16, 2018
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    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. INVESTIGATION IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    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: (B)(4). PROBLEM STATEMENT: ¿THE STENT DID NOT OPEN. DURING THE PROCEDURE THE TRIGGER DOESN'T WORK, I SAW THE PRODUCT AND I THINK THAT THE DOCTOR PROBABLY DIDN'T PRESS VERY WELL THE BUTTON¿. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. DEVICE EVALUATION: THE EVO-22-27-9-D DEVICE OF LOT NUMBER: C1347247 WAS RETURNED TO COOK IRELAND AND A LABORATORY EVALUATION WAS PERFORMED. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS FOUND THAT THE TRIGGER AND THE OUTER SHEATH WERE NOT ACTING TOGETHER, I.E. NO DEPLOYMENT OR RETRACTION WAS POSSIBLE. THE HANDLE WAS DISMANTLED DURING THE LAB. THE FLEXOR WAS BROKEN IN THE HANDLE AT THE SHUTTLE CAP. THE STENT WAS MANUALLY DEPLOYED WITH NO RESISTANCE. THERE WERE NO ISSUES NOTED WITH THE STENT. CUSTOMER COMPLAINT CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING THE LAB EVALUATION. ROOT CAUSE: THE DEVICE WAS RETURNED FOR EVALUATION AND A POSSIBLE CAUSE FOR THE ISSUE OCCURRING MAY BE DUE TO DELAMINATION OF THE PTFE LINER OF THE OUTER SHEATH. DOCUMENT 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. UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS OCCURRED PREVIOUSLY WITH THIS LOT NUMBER: C1347247. BASED ON INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH LOT NUMBER: C1333804. 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: NO ADVERSE EVENTS WERE REPORTED AS A RESULT OF THIS OCCURRENCE. THE PROCEDURE WAS COMPLETED BY PLACING WITH ANOTHER STENT. CUSTOMER COMPLAINT CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING THE LAB EVALUATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS. H3 OTHER TEXT : COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF CUSTOMER COMPLAINT CONFIRMED AS FAILURE WAS VERIFIED IN LABORATORY. THE FLEXOR WAS SEEN TO BE BROKEN AT THE SHUTTLE CAP DURING THE LAB EVALUATION. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    THE STENT DID NOT OPEN.

    Description of Event or Problem · 0

    THE STENT DID NOT OPEN. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361461 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1