BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5313154 · Received December 21, 2015

    Report

    Report Number
    3001845648-2015-00297
    Event Type
    Injury
    Date Received
    December 21, 2015
    Date of Event
    October 29, 2015
    Report Date
    November 23, 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. REPORTING REQUIRED BASED ON THE MEDICAL INTERVENTION CARRIED OUT [ADMINISTRATION OF ANTIBIOTICS] AS A RESULT OF THE OCCURRENCE OF CHOLANGITIS POST PLACEMENT OF THE EVOLUTION DEVICE. CHOLANGITIS IS A NOTED COMPLICATION WITH BILIARY STENT PLACEMENT AND COULD BE INDIRECTLY RELATED TO A PERFORMANCE RELATED ISSUE WITH THE EVO DEVICE. STENT MIGRATION ALSO MEETS THE CRITERIA OF A MALFUNCTION PRECEDENCE REPORT. PMA/510K)# OF 'SIMILAR DEVICE' AS FOLLOWS: K121430. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION; THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. THE CUSTOMER COMPLAINT WAS CONFIRMED BASED ON THE CUSTOMER TESTIMONY. FROM THE INFORMATION PROVIDED ¿ASSESSMENTS WERE NOT COMPLETED AT THREE, FOUR AND FIVE MONTHS POST-PROCEDURE.¿ THE INSTRUCTIONS FOR USE STATES THE FOLLOWING IN THE ¿PRECAUTIONS¿ SECTION ¿PERIODIC EVALUATION OF THE STENT IS ADVISED¿ ALSO, POST THE PROCEDURE, INFORMATION WAS PROVIDED 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 EVO-FC-10-11-6-B DEVICES ARE SUBJECTED TO 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 NO DISCREPANCIES RELATED TO THIS COMPLAINT ISSUE. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    (B)(4). ON THE DAY OF THE PROCEDURE ((B)(6) 2015) THE BILIARY STRICTURE MEASURED 1 CM AND WAS LOCATED IN THE COMMON BILE DUCT BELOW THE CYSTIC DUCT. NO TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. A PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED OVER A PRE-EXISTING SPHINCTEROTOMY. PRE-STENT DILATION WAS NOT PERFORMED; HOWEVER, BILE DUCT BRUSHING WAS PERFORMED PRIOR TO STENT PLACEMENT. A 10 MM X 6 CM EVOLUTION BILIARY STENT-FULLY COVERED (C903727) WAS PLACED AT THE INTENDED LOCATION. STENT DEPLOYMENT WAS CONSIDERED EASY. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA AND FLUOROSCOPY CONFIRMED RELIEF OF OBSTRUCTION. THE SITE NOTED THAT THEY WERE SATISFIED WITH THE QUALITY AND PERFORMANCE OF THE STUDY DEVICE. AT 35 DAYS POST-PROCEDURE THE ONE MONTH FOLLOW-UP TELEPHONE ASSESSMENT WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. ON THE FOLLOWING DAY (36 DAYS POST-PROCEDURE), TOTAL BILIRUBIN WAS 2.4 MG/DL. AT 70 DAYS POST-PROCEDURE THE TWO MONTH FOLLOW-UP TELEPHONE ASSESSMENT WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. ASSESSMENTS WERE NOT COMPLETED AT THREE, FOUR AND FIVE MONTHS POST-PROCEDURE. ON (B)(6) 2015 (167 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED WITH CHOLANGITIS AND TREATED WITH ANTIBIOTICS. THE PATIENT WAS DISCHARGED ON (B)(6) 2015 (169 DAYS POST-PROCEDURE). ON THE SAME DAY THE 6 MONTH FOLLOW-UP TELEPHONE ASSESSMENT WAS COMPLETED. THE PATIENT HAD UNDERGONE TUMOR REDUCTION THERAPY (CHEMOTHERAPY) SINCE THE LAST CONTACT. PER TELEPHONE CORRESPONDENCE, THE SITE NOTED THAT A CT SCAN DONE ON (B)(6) 2015 (171 DAYS POST-PROCEDURE), INDICATED THAT THE DUCT WAS STILL DILATED, HOWEVER, THE STENT WAS NO LONGER IN PLACE, "THERE WAS NO SIGN OF STENT."THE SITE ALSO NOTED THAT "BILIRUBIN WAS IN NORMAL RANGE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    839983 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR