BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 6954617 · Received October 17, 2017

    Report

    Report Number
    3001845648-2017-00473
    Event Type
    Malfunction
    Date Received
    October 17, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 18, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) # "K101530 AND K163468." (B)(4). EXEMPTION NUMBER: E2016031. (B)(4). THIS REPORT IS BEING SUBMITTED DUE CORRECTIONS: IT MAY BE NOTED THAT A PROJECT HAS BEEN ASSIGNED TO PRODUCT DEVELOPMENT TO FURTHER INVESTIGATE STENT DEPLOYMENT ISSUES OF THIS NATURE IN AN EFFORT TO ELIMINATE FUTURE OCCURRENCES.

    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: "THEY STARTED TO DEPLOY THE STENT AND HEARD A POPPING SOUND IN THE HANDLE AND WOULD NOT DEPLOY. THEY DEPLOYED IT MANUALLY AFTER OPENING TOP OF THE GUN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY." THE DEVICE INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR RETURN TO COOK IRELAND FOR EVALUATION. 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 DURING USE. A POSSIBLE CAUSE FOR THE ISSUE OCCURRING 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 DEVICE REVEALED ONE UNIT WAS SCRAPPED FOR AN NC ¿FLEXOR BUNCHING¿; AS THIS UNIT WAS SCRAPPED IT WOULD THEREFORE NOT HAVE AN IMPACT ON THE ISSUE INVOLVED IN THIS COMPLAINT, NO OTHER DISCREPANCIES WERE REVEALED THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT 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 VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED, THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    FOLLOW UP REPORT IS BEING SUBMITTED DUE TO CORRECTIONS. THEY STARTED TO DEPLOY THE STENT AND HEARD A POPPING SOUND IN THE HANDLE AND WOULD NOT DEPLOY. THEY DEPLOYED IT MANUALLY AFTER OPENING TOP OF THE GUN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Description of Event or Problem · 0

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE OF 'FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED' THEY STARTED TO DEPLOY THE STENT AND HEARD A POPPING SOUND IN THE HANDLE AND WOULD NOT DEPLOY. THEY DEPLOYED IT MANUALLY AFTER OPENING TOP OF THE GUN. THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734264 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48026 C1304071 10827002480268

    Patients

    Seq Age Sex Outcome Treatment
    1