BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 8235795 · Received January 10, 2019

    Report

    Report Number
    3001845648-2019-00011
    Event Type
    Injury
    Date Received
    January 10, 2019
    Date of Event
    December 13, 2018
    Report Date
    January 10, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480251
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; 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 IS STILL PENDING. A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    510 (K) NUMBER; K163468. COOK IRELAND LTD (MANUFACTURER) IS SUBMITTING THIS REPORT ON BEHALF OF COOK MEDICAL INCORPORATED (CMI)(IMPORTER). EXEMPTION NUMBER: E2016031 INFORMATION PERTAINING TO MFR SITE AS FOLLOWS: IMPORTER SITE CONTACT AND ADDRESS: (B)(6). (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). LAB EVALUATION: THE EVO-22-27-6-D DEVICE OF LOT NUMBER: C1546233 WAS UNAVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, DOCUMENT BASED INVESTIGATION WAS CONDUCTED. AS PER CUSTOMER TESTIMONY "THE STENT DEPLOYED PERFECTLY." DOCUMENTS REVIEW INCLUDING IFU REVIEW: PRIOR TO DISTRIBUTION ALL EVO-22-27-6-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 QC DID NOT REVEAL ANY ISSUES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. A REVIEW OF THE MANUFACTURING RECORDS FOR EVO-22-27-6-D DEVICE OF LOT NUMBER: C1546233 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#: C1546233; UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT#: C1546233. THE INSTRUCTIONS FOR USE IFU0053-9 WHICH ACCOMPANIES THIS DEVICE INSTRUCTS THE USER TO "WHEN STENT POINT -OF -NO RETURN HAS BEEN PASSED, PULL SAFETY WIRE OUT OF DELIVERY HANDLE NEAR WIRE GUIDE PORT." THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE ( IFU0053-9). ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO KINKED FLEXOR OR TORTUOUS ANATOMY. POTENTIALLY FLEXOR MAY HAVE GOTTEN KINKED ON INSERTION INTO SCOPE CAUSING TRIGGER WIRE VERY DIFFICULT TO RELEASE. THE FORCE REQUIRED TO REMOVE THE SAFETY WIRE COULD HAVE CONTRIBUTED TO THE DEPLOYMENT OF THE STENT BEYOND THE TARGETED SITE AS PER THE ENGINEERING ASSESSMENT: "DURING THE DIFFICULT REMOVAL OF THE SAFETY WIRE (DELIVERY SYSTEM IN ONE HAND APPLYING DISTAL FORCE AND SAFETY WIRE IN THE OTHER HAND APPLYING PROXIMAL FORCE) IT¿S LIKELY DISTAL FORCE WAS APPLIED TO THE DELIVERY SYSTEM IN ORDER TO REMOVE THE SAFETY RESULTING IN A DELIVERY SYSTEM/STENT DISTAL MOVEMENT. THIS WOULD HAVE CONTRIBUTED TO STENT DEPLOYMENT SIGNIFICANTLY PASS THE INTENDED TARGET SITE," SUMMARY: ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMER'S TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    DURING DEPLOYMENT, THE YELLOW MARKER WAS IN VIEW AND UPON 50% DEPLOYMENT, THE USER PULLED THE SAFETY WIRE BUT IT WAS EXTREMELY DIFFICULTY TO REMOVE. THE WIRE WAS REMOVED WITH FORCE, AND THE STENT DEPLOYED SIGNIFICANTLY PAST THE INTENDED TARGET SITE. ANOTHER STENT IS SCHEDULED TO BE PLACED ON (B)(6) 2018.

    Description of Event or Problem · 0

    DURING DEPLOYMENT, THE YELLOW MARKER WAS IN VIEW AND UPON 50% DEPLOYMENT, THE USER PULLED THE SAFETY WIRE BUT IT WAS EXTREMELY DIFFICULTY TO REMOVE. THE WIRE WAS REMOVED WITH FORCE, AND THE STENT DEPLOYED SIGNIFICANTLY PAST THE INTENDED TARGET SITE. ANOTHER STENT IS SCHEDULED TO BE PLACED ON (B)(6) 2018. ADDITIONAL INFORMATION RECEIVED: WHAT IS THE OVERALL OUTCOME OF THE INTERVENTIONAL PROCEDURE? THE STENT DEPLOYED PERFECTLY. WAS THERE ANY DIFFICULTY NOTED DURING THE INTERVENTIONAL PROCEDURE? NOT AT ALL . ARE ANY IMAGES AVAILABLE TO AID IN INVESTIGATION? NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    30761 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48025 C1546233 10827002480251

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention