BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 8420537 · Received March 14, 2019

    Report

    Report Number
    3001845648-2019-00103
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    February 14, 2019
    Report Date
    March 14, 2019
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231303
    PMA / PMN Number
    K121430
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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)(6). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). 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. IMPORTER SITE CONTACT AND ADDRESS: (B)(6). COOK MEDICAL INCORPORATED (CMI) (B)(4). IMPORTER SITE ESTABLISHMENT REGISTRATION NUMBER: (B)(4). THE DEVICE INVOLVED IN THE COMPLAINT WAS EVALUATED IN THE LABORATORY ON 25TH APRIL 2019. NO VISUAL DEFECT FOUND IN THE LABORATORY. STENT DEPLOYED WITH HIGH RESISTANCE POSSIBLY DUE TO KINK. WHEN DEVICE AND INTRODUCER WAS STRAIGHTEN OUT THERE WAS A GREAT DECREASE IN THE RESISTANCE. PRIOR TO DISTRIBUTION ALL EVO-10-11-10-B DEVICES ARE SUBJECT TO VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. THERE INSPECTIONS AND FUNCTIONAL CHECKS ARE OUTLINED IN INTERNAL PROCEDURES IN PLACE AT CIRL UPON REVIEW OF COMPLAINTS, THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THE LOT NUMBER C1335622. BASED ON THE INFORMATION AVAILABLE TO DATE, THERE IS NO EVIDENCE TO SUGGEST THAT THERE ARE ANY MANUFACTURING ISSUES ASSOCIATED WITH THE LOT NUMBER C1335622 A REVIEW OF THE MANUFACTURING RECORDS FOR C1335622 DID NOT REVEAL ANY DISCREPANCIES WHICH COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS FOR USE (IFU0056-5). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED AS THE CIRCUMSTANCES OF USE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT ANATOMY. COMPLAINT IS CONFIRMED BASED ON THE CUSTOMERS TESTIMONY AS THE CLINICAL SETTING THAT COULD IMPACT ON THE FUNCTIONALITY OF THE DEVICE CANNOT BE REPLICATED IN THE LABORATORY. A POSSIBLE ROOT CAUSE COULD BE ATTRIBUTED TO PATIENT ANATOMY. ACCORDING TO THE INFORMATION REPORTED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/COMPRESSED'. STENT NOT RELEASING DURING TRIGGERING COULD NOT BE DEPLOYED.

    Description of Event or Problem · 0

    EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/COMPRESSED'. STENT NOT RELEASING DURING TRIGGERING COULD NOT BE DEPLOYED.

    Description of Event or Problem · 0

    EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿FLEXOR KINKED/ STRETCHED/ BROKEN/COMPRESSED' AND "DEPLOYMENT ISSUE RESULTING IN STENT DEPLOYED IN INCORRECT LOCATION'. DEVICE WAS RETURNED AND EVALUATED ON THE 25-APR-19 CONFIRMING THE STENT WAS PARTIALLY DEPLOYED ON RETURN. STENT NOT RELEASING DURING TRIGGERING COULD NOT BE DEPLOYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215618 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL FGE COOK IRELAND LTD G23130 C1335622 10827002231303

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR