BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5317590 · Received December 22, 2015

    Report

    Report Number
    3001845648-2015-00300
    Event Type
    Injury
    Date Received
    December 22, 2015
    Date of Event
    October 16, 2015
    Report Date
    November 30, 2015
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). THIS SPECIFIC EVOLUTION DEVICE IS CURRENTLY NOT REGISTERED FOR SALE IN THE US. HOWEVER, THIS DEVICE IS CONSIDERED 'SIMILAR' TO OTHER METAL BILIARY STENTS/SETS (EVOLUTION) DEVICES CURRENTLY MARKETED IN THE US THEREFORE MDR REPORTING CRITERIA APPLICABLE TO THIS EVENT. PMA/510(K) OF 'SIMILAR DEVICE' AS FOLLOWS: K121430. INCIDENT MEETS REPORTING CRITERIA OF AN FDA MDR REPORT BASED ON THE INTERVENTION CARRIED OUT AS A RESULT OF THE MIGRATION OF THE EVOLUTION STENT. PATIENT WAS SYMPTOMATIC FOLLOWING STENT MIGRATION. THE DEVICE RELATED TO THIS COMPLAINT IS NOT AVAILABLE FOR EVALUATION, AS THE STENT REMAINS IMPLANTED IN THE PATIENT. WITH THE INFORMATION PROVIDED A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. AS PER THE INSTRUCTIONS FOR USE, POTENTIAL COMPLICATIONS INCLUDE MIGRATION. ALSO INFORMATION WAS PROVIDED POST THE PROCEDURE THAT THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY). THE PRECAUTIONS SECTION OF THE INSTRUCTIONS FOR USE STATES THE FOLLOWING ¿AFTER STENT PLACEMENT, ADDITIONAL METHODS OF TREATMENT SUCH AS CHEMOTHERAPY AND IRRADIATION MAY INCREASE THE RISK OF STENT MIGRATION DUE TO TUMOR SHRINKAGE, STENT EROSION, AND/OR MUCOSAL BLEEDING.¿ PRIOR TO DISTRIBUTION ALL EVOLUTION 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 LOT C903727 REVEALED THAT THE EXPIRY DATE FOR THIS DEVICE WAS 05 JULY 2015. AS PER THE INFORMATION PROVIDED THE DATE OF THE PROCEDURE WAS 17 JULY 2015. NO OTHER DISCREPANCIES WERE NOTED THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. FROM THE INFORMATION PROVIDED, THE BILIARY OCCLUSION WAS DISTAL TO THE STUDY STENT DUE TO PARTIAL PROXIMAL STENT MIGRATION. MIGRATION WAS CONFIRMED AND AN INCREASE IN TUMOR SIZE WAS SUSPECTED TO BE A CONTRIBUTING FACTOR. TREATMENT INCLUDED PLACEMENT OF A NON-STUDY BILIARY STENT DISTAL TO THE STUDY STENT. THE STUDY INVESTIGATOR INDICATED THAT THE EVENT WAS UNLIKELY RELATED TO EITHER THE STUDY DEVICE OR STUDY PROCEDURE AND INDICATED THAT PRE-EXISTING ¿STUDY DISEASE¿ CAUSED OR CONTRIBUTED TO THE EVENT. THE SITE MARKED NO TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE? COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(6). ON THE DAY OF THE PROCEDURE ((B)(6) 2015) THE BILIARY STRICTURE MEASURED 2 CM IN LENGTH AND WAS LOCATED IN THE COMMON BILE DUCT BELOW THE CYSTIC DUCT. MILD TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT AND NO PRE-STENT DILATION WAS PERFORMED. A 10 MM X 6 CM (C903727) EVOLUTION BILIARY STENT-FULLY COVERED WAS PLACED AT THE INTENDED LOCATION. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND THERE WAS VISUAL CONFIRMATION OF (BILE FLOW) RELIEF OF OBSTRUCTION. NO ADDITIONAL PROCEDURES WERE PERFORMED. THE SITE NOTED THAT THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF THE STUDY DEVICE. AT 33 DAYS POST-PROCEDURE THE ONE MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. TOTAL BILIRUBIN COMPLETED 34 DAYS POST PROCEDURE WAS 0.89 MG/DL. AT 61 DAYS POST-PROCEDURE THE TWO MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. AT 90 DAYS POST-PROCEDURE THE THREE MONTH FOLLOW-UP WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. ON (B)(6) 2015 (91 DAYS POST-PROCEDURE), THE PATIENT EXPERIENCED SYMPTOMATIC RECURRENT BILIARY OBSTRUCTION (SEVERE ABDOMINAL PAIN, DARK URINE). ON THE SAME DAY TOTAL BILIRUBIN WAS 2.57 MG/DL. IT WAS NOTED THAT BILIARY OCCLUSION WAS DISTAL TO THE STUDY STENT DUE TO PARTIAL PROXIMAL STENT MIGRATION. MIGRATION WAS CONFIRMED WITH ENDOSCOPY, AND AN INCREASE IN TUMOR SIZE WAS SUSPECTED TO BE A CONTRIBUTING FACTOR. TREATMENT INCLUDED PLACEMENT OF A NON-STUDY BILIARY STENT DISTAL TO THE STUDY STENT. THE STUDY INVESTIGATOR INDICATED THAT THE EVENT WAS UNLIKELY RELATED TO EITHER THE STUDY DEVICE OR STUDY PROCEDURE AND INDICATED THAT PRE-EXISTING "STUDY DISEASE" CAUSED OR CONTRIBUTED TO THE EVENT. THE INVESTIGATOR DID NOT CONSIDER THIS EVENT TO BE SERIOUS. THE SITE MARKED NO TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844446 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR