BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED

    MDR report key: 5499947 · Received March 15, 2016

    Report

    Report Number
    3001845648-2016-00071
    Event Type
    Injury
    Date Received
    March 15, 2016
    Date of Event
    February 1, 2016
    Report Date
    February 17, 2016
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    UDI-DI
    10827002231341
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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/510K)# OF 'SIMILAR DEVICE': K121430. THE DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT CONFIRMED BASED ON THE CUSTOMERS¿ TESTIMONY. 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 C897337 REVEALED NO DISCREPANCIES THAT COULD HAVE CONTRIBUTED TO THIS COMPLAINT ISSUE. IT WAS NOTED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND NOT RELATED TO THE STUDY PROCEDURE. THE SITE MARKED YES TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE AND ALSO MARKED YES TO THE QUESTION AS PER THE LISTED ¿POTENTIAL COMPLICATIONS¿ IN THE INSTRUCTIONS FOR USE ¿POTENTIAL COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: PANCREATITIS, CHOLANGITIS, CHOLECYSTITIS, CHOLESTASIS, ASPIRATION, PERFORATION, HEMORRHAGE, INFECTION, SEPSIS, ALLERGIC REACTION TO CONTRAST OR MEDICATION, HYPOTENSION, RESPIRATORY DEPRESSION OR ARREST, CARDIAC ARRHYTHMIA OR ARREST.¿ COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    STUDY: 10-014 EVOLUTION BILIARY STENT SYSTEM-FULLY COVERED; PATIENT: (B)(6) - RECURRENT BILIARY OBST. (STENT OCCLUSION). ON THE DAY OF THE PROCEDURE ((B)(6) 2015) THE BILIARY STRICTURE MEASURED 1.5 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. NO PRE-STENT DILATION WAS PERFORMED. A 10 MM X 6 CM EVOLUTION BILIARY STENT-FULLY COVERED (C897337) WAS THEN PLACED AT THE INTENDED LOCATION. STENT DEPLOYMENT WAS CONSIDERED VERY 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 28 DAYS POST PROCEDURE, BLOOD WORK REVEALED A TOTAL BILIRUBIN OF 2.16 MG/DL. THE PATIENT HAD NOT UNDERGONE ANY TYPE OF TUMOR REDUCTION THERAPY THROUGH THE 9 MONTH FOLLOW-UP. ON (B)(6) 2016 (333 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED WITH SYMPTOMS OF RECURRENT BILIARY OBSTRUCTION (SEVERE ABDOMINAL PAIN, MODERATE JAUNDICE, DARK URINE). ENDOSCOPY IDENTIFIED OCCLUSION OF THE STUDY STENT (SLUDGE, PUS). A NON-STUDY UNCOVERED METAL STENT WAS PLACED THROUGH THE STUDY STENT. ADDITIONAL BLOOD WORK DONE ON (B)(6) 2016 REVEALED A TOTAL BILIRUBIN OF 5.61 MG/DL. IT WAS NOTED THAT THIS EVENT WAS POSSIBLY RELATED TO THE STUDY PRODUCT AND NOT RELATED TO THE STUDY PROCEDURE. THE SITE MARKED YES TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE AND ALSO MARKED YES TO THE QUESTION: COULD THIS EVENT HAVE LED TO DEATH OR SERIOUS DETERIORATION IN HEALTH HAD SUITABLE INTERVENTION NOT OCCURRED? THE SITE HAS BEEN QUERIED TO CONFIRM AND PROVIDE ADDITIONAL INFORMATION REGARDING THEIR ASSESSMENT OF DEVICE MALFUNCTION. ADDITIONAL INFORMATION PROVIDED; ON THE SAME DATE ((B)(6) 2016), IN ADDITION TO BILIARY OBSTRUCTION, THE PATIENT WAS DIAGNOSED WITH CHOLANGITIS AND SUCCESSFULLY TREATED WITH ANTIBIOTICS. IT WAS NOTED THAT BOTH EVENTS (RECURRENT BILIARY OBSTRUCTION AND CHOLANGITIS) WERE POSSIBLY RELATED TO THE STUDY PRODUCT AND NOT RELATED TO THE STUDY PROCEDURE. FOR BOTH, THE SITE MARKED YES TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE AND ALSO MARKED YES TO THE QUESTION: COULD THIS EVENT HAVE LED TO DEATH OR SERIOUS DETERIORATION IN HEALTH HAD SUITABLE INTERVENTION NOT OCCURRED? THE SITE WAS QUERIED TO CONFIRM AND PROVIDE ADDITIONAL INFORMATION REGARDING THEIR ASSESSMENT OF DEVICE MALFUNCTION FOR BILIARY OBSTRUCTION. ON (B)(6) 2016 THE SITE PROVIDED THE FOLLOWING COMMENT, "AFTER DISCUSSION WITH DR. MOSKO WE CONCLUDED THAT THIS WAS A CASE OF DEVICE MALFUNCTION. ATTEMPTS TO REMOVE THE FULLY COVERED BILIARY STENT WERE UNSUCCESSFUL WITH BOTH FORCEPS AND SNARE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    158784 EVOLUTION® BILIARY CONTROLLED-RELEASE STENT - FULLY COVERED FGE COOK IRELAND LTD 10827002231341

    Patients

    Seq Age Sex Outcome Treatment
    1 93 YR Required Intervention