BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 7028024 · Received November 14, 2017

    Report

    Report Number
    3001845648-2017-00542
    Event Type
    Malfunction
    Date Received
    November 14, 2017
    Date of Event
    July 18, 2017
    Report Date
    October 18, 2017
    Manufacturer
    COOK IRELAND LTD
    Product Code
    MUM
    UDI-DI
    10827002480275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LE
    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 COMPLAINT INFORMATION REPORTED WAS AS FOLLOWS: ¿EVOLUTION METALLIC STENT DUODENAL 12 CM: DURING THE PROCEDURE AND WHEN THE STENT WAS IN PLACE AND NEEDS DEPLOYMENT, THE STENT DID NOT OPEN, HANDLE WAS BLOCKED DESPITE SEVERAL ATTEMPTS TO DEPLOY; STENT WAS REMOVED AND ANOTHER ONE WAS USED.¿ THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: -WHEN THE STENT WAS IN PLACE - DO THEY MEAN THE STENT WAS IN THE BODY OR ARE THEY REFERRING TO THE ENTIRE DEVICE SYSTEM IN PLACE? "IT WAS IN THE BODY" -THE STENT DID NOT OPEN - DO THEY MEAN THE STENT DID NOT DEPLOY OR THE STENT DID OPEN ONCE DEPLOYED IN PLACE? "THE STENT DID NOT DEPLOY" -THE STENT WAS REMOVED - DO THEY MEAN THE STENT WAS REMOVED FROM WITHIN THE BODY OR ARE THEY REFERRING TO THE ENTIRE DEVICE SYSTEM BEING REMOVED? "IT WAS REMOVED THE ENTIRE DEVICE FROM WITHIN THE BODY" -WAS THE STENT EVER WITHIN THE BODY POST - DEPLOYMENT? OR IS IT THAT THE STENT COULD NOT DEPLOY AT ALL? "THE STENT COULD NOT DEPLOY AT ALL." 1 X EVO-22-27-12-D WAS RETURNED TO CIRL FOR EVALUATION. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS NOTED THAT THERE WAS A KINK IN THE FLEXOR AT THE HANDLE ON RETURN OF THE DEVICE WHICH COULD HAVE BEEN DUE TO RETURN CONDITIONS OF THE DEVICE. THIS HAD NO IMPACT ON THE FUNCTIONING OF THE DEVICE AS IT WAS POSSIBLE TO ACTUATE THE DEVICE FOR DEPLOYMENT AND RETRACTION WITHOUT ISSUE. THE LOCKWIRE AND STENT WERE NOT RETURNED. NO FUNCTIONAL ISSUE COULD BE FOUND WITH THE COMPLAINT DEVICE DURING LAB EVALUATION. THE FOLLOWING INFORMATION WAS RECEIVED POST LAB EVALUATION: ¿WHEN THE STENT WAS IN PLACE AND NEEDS DEPLOYMENT, THE STENT DID NOT OPEN¿ DO THEY MEAN THAT THE STENT WOULDN¿T PHYSICALLY EXPAND OR DO THEY MEAN THAT THE HANDLE WOULD NOT DEPLOY THE STENT? ¿THE STENT WOULDN'T PHYSICALLY EXPAND". ARE THERE ANY IMAGES OF THE STENT? FLUORO/ENDO OR OTHER.¿ "IN THE HOSPITAL THEY DID NOT PROVIDE US WITH ANY IMAGES OF THE STENT.¿ FURTHER CLARIFICATION WAS THEN PROVIDED: ¿THE STENT DIDN'T PHYSICALLY EXPAND OR THE STENT DID NOT DEPLOY, BOTH WAYS THE STENT WAS NOT OUT OF THE HANDLE. THE NURSE IN CHARGE MAY HAVE DEPLOYED IT OUTSIDE THE PATIENT AFTER.¿ 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. IT IS ASSUMED THAT THE STENT WAS DEPLOYED ONCE THE DEVICE WAS REMOVED FROM THE PATIENT AND DISCARDED. AS USAGE CONDITIONS CANNOT BE REPLICATED WITHIN THE LABORATORY SETTING, A DEFINITIVE ROOT CAUSE CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS POSSIBLE THAT PATIENT ANATOMY OR PROCEDURE CONDITIONS MAY HAVE HAD AN IMPACT ON DEPLOYMENT AS THE DEVICE SEEMS TO BE FUNCTIONING AS INTENDED. A REVIEW OF THE MANUFACTURING RECORDS FOR THE EVO-22-27-12-D REVEALED 01 UNIT WAS SCRAPPED FOR ¿HANDLE NOT MOVING¿ DUE TO A BROKEN GREY COG AND 04 UNITS WERE SCRAPPED FOR ¿SHEATH/FLEXOR OUT OF SPEC¿ AS THESE UNITS WERE SCRAPPED THEY 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. PRIOR TO DISTRIBUTION ALL EVO-22-27-12-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. THERE IS NO EVIDENCE TO SUGGEST THAT THIS ISSUE EFFECTS THE ENTIRE LOT, UPON REVIEW OF COMPLAINTS THIS FAILURE MODE HAS NOT OCCURRED PREVIOUSLY WITH THIS LOT #. THE NOTES SECTION OF THE IFU 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 VIABLE EVIDENCE TO SUGGEST THAT THE USER DID NOT FOLLOW THE INSTRUCTIONS FOR USE. FROM THE INFORMATION PROVIDED THERE WERE NO ADVERSE EFFECTS TO THE PATIENT DUE TO THIS OCCURRENCE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR EMERGING TRENDS.

    Description of Event or Problem · 0

    INITIAL MDR IS BEING SUBMITTED BASED ON THE DEVICE MALFUNCTION PRECEDENCE: ¿FLEXOR KINKED/STRETCHED/BROKE/COMPRESSED". EVOLUTION METALLIC STENT DUODENAL 12 CM: DURING THE PROCEDURE AND WHEN THE STENT WAS IN PLACE AND NEEDS DEPLOYMENT, THE STENT DID NOT OPEN , HANDLE WAS BLOCKED DESPITE SEVERAL ATTEMPTS TO DEPLOY; STENT WAS REMOVED AND ANOTHER ONE WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    810681 EVOLUTION® DUODENAL CONTROLLED-RELEASE STENT - UNCOVERED MUM STENT, METALIC EXPANDABLE, DUODENAL MUM COOK IRELAND LTD G48027 10827002480275

    Patients

    Seq Age Sex Outcome Treatment
    1