BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT- UNCOVERED

    MDR report key: 3954842 · Received July 17, 2014

    Report

    Report Number
    3001845648-2014-00133
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    May 29, 2014
    Report Date
    June 20, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE MALFUNCTION HAS BEEN REPORTED OR CONFIRMED BY THE USER FACILITY. HOWEVER, THIS REPORT MEETS THE CRITERIA OF AN FDA MDR REPORT BASED ON THE HOSPITALISATION OF THE PATIENT AND INTERVENTION TO MANAGE A GL BLEED 14 DAYS POST PLACEMENT OF THE EVOLUTION BILIARY STENT. ULCERS NOTED AT STENT SITE ALSO. THERE WERE NO EVO-10-11-4-B DEVICES OF LOT# C977905 IN STOCK AT THE TIME OF THE COMPLAINT INVESTIGATION. THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION. IMAGES HAVE BEEN REQUESTED BUT HAVE NOT BEEN RECEIVED TO DATE. A DOCUMENT BASED INVESTIGATION WAS CARRIED OUT. AS PER DR BARRON'S PUBLICATION { "ERCP", 2ND EDITION, AUTHORS TODD H BARON, RICHARD A. KOZAREK AND DAVID L. CARR-LOCKE) TRANSPAPILLARY SEMS THAT EXTEND MUCH FARTHER INCREASE THE RISK FOR MECHANICAL TRAUMA TO THE OPPOSITE DUODENAL WALL WITH POTENTIAL FOR DEVELOPMENT OF ULCERATION, BLEEDING, AND PERFORATION. A MALPOSITIONED SEMS MAY PERFORATE THE BILE DUCT WALL OR PRODUCE ULCERATION, BLEEDING, AND PERFORATION OF THE OPPOSITE DUODENAL WALL. SPHINCTEROTOMY BLEEDING OCCURS PRIMARILY IN PATIENTS WITH BILE DUCT STONES, AND CHOLANGITIS MOSTLY IN PATIENTS WITH MALIGNANT BILIARY OBSTRUCTION. BLEEDING AFTER SPHINCTEROTOMY CAN MOSTLY BE AVOIDED BY AVOIDING SPHINCTEROTOMY IN PATIENTS WITH RISK FACTORS SUCH AS COAGULOPATHY. BALLOON DILATION OF THE BILIARY SPHINCTEROTOMY CAN BE SUBSTITUTED OR ADDED TO SPHINCTEROTOMY IN HIGHER RISK PATIENTS. ONCE SPHINCTEROTOMY IS UNDERTAKEN, RISK CAN BE MINIMIZED BY CORRECTION OF ANY COAGULOPATHIES, BY WITHHOLDING ANTICOAGULANT MEDICATIONS FOR AS MANY AS 3 DAYS AFTERWARD, AND BY USE OF METICULOUS ENDOSCOPIC TECHNIQUE. PROPHYLACTIC INJECTION OF THE SPHINCTEROTOMY SITE WITH EPINEPHRINE IN PATIENTS WITH COAGULOPATHY MAY REDUCE RISK OF HEMORRHAGE. THE RELEVANT ENGINEER HAS STATED THAT IN RELATION TO POINTS 1 AND 2 ABOVE IT WAS A SHORT STENT THAT WAS PLACED IN THIS INSTANCE MAKING IMPACTING THE DUODENAL WALL UNLIKELY OR THE STENT WOULD HAVE MIGRATED. COMMENTS IN RELATION TO POINT 3 WERE THAT SPHINCTEROTOMY BLEEDING CAN REGULARLY OCCUR LEADING TO ULCERATION AND IT IS RECOMMENDED NOT PERFORMING A SPHINCTEROTOMY ON HIGHER RISK PATIENTS. FROM THE INFORMATION PROVIDED, IT CAN BE SEEN THAT THIS WAS A HIGHER RISK PATIENT. THE INSTRUCTIONS FOR USE FOR THIS DEVICE STATES THE FOLLOWING IN THE "PRECAUTIONS" SECTION: "ASSESSMENT MUST BE MADE TO DETERMINE THE NECESSITY OF A SPHINCTEROTOMY OR BALLOON DILATION PRIOR TO STENT PLACEMENT. IN THE EVENT OF SPHINCTEROTOMY OR BALLOON DILATION IS REQUIRED, ALL APPROPRIATE CAUTIONS, WARNINGS AND CONTRAINDICATIONS MUST BE OBSERVED." THE INSTRUCTIONS FOR USE ALSO LISTS BILE DUCT ULCERATION AS A POTENTIAL COMPLICATION. THE CUSTOMER INDICATED THAT THE PATIENT'S PRE-EXISTING CONDITION (PREVIOUS HISTORY OF ULCERS) MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. AS THE DEVICE HAS NOT BEEN RETURNED THE CAUSE OF THE COMPLAINT COULD NOT BE CONCLUSIVELY DETERMINED. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. PRIOR TO DISTRIBUTION ALL EVO-10-11-4-B DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE MANUFACTURING RECORDS FOR LOT C977905 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

    A (B)(6) MALE PRESENTED AT THE TIME OF ENROLLMENT (STUDY (B)(4)) WITH A HISTORY OF STAGE 3 PANCREATIC CANCER AND WAS NOT UNDERGOING ADJUNCTIVE TUMOR REDUCTION THERAPY. TOTAL BILIRUBIN COMPLETED ON (B)(6) 2014 WAS 1.5 MG/DL. ON THE DAY OF THE PROCEDURE ((B)(6) 2014) THE BILIARY STRICTURE MEASURED 3 CM AND WAS LOCATED IN THE COMMON BILE DUCT. PRIOR TO STENT PLACEMENT, A PREVIOUSLY PLACED PLASTIC STENT WAS REMOVED AND SPHINCTEROTOMY WAS PERFORMED. A 10 MM X 4 CM ((B)(4)) EVOLUTION BILIARY STENT, UNCOVERED WAS PLACED WITHOUT DIFFICULTY AT THE INTENDED LOCATION. THERE WAS NO PRE OR POST-STENT DILATION PERFORMED. AT THE COMPLETION OF THE PROCEDURE THE DISTAL END OF THE STENT CROSSED THE PAPILLA. NO ADDITIONAL PROCEDURES WERE PERFORMED. ON (B)(6) 2014 (14 DAYS POST-PROCEDURE), THE PATIENT WAS HOSPITALIZED AND UNDERWENT ENDOSCOPY FOR GL BLEEDING. ULCERATION WAS NOTED AT THE SITE OF THE STENT, HOWEVER, NO FURTHER INTERVENTION WAS REQUIRED. THE STUDY PHYSICIAN INDICATED THAT THE EVENT WAS "POSSIBLY" DUE TO THE STUDY PROCEDURE AND "POSSIBLY" DUE TO THE STUDY DEVICE. PATIENT ALSO HAD A PRE-EXISTING CONDITION (PREVIOUS HISTORY OF ULCERS) THAT MAY HAVE CAUSED OR CONTRIBUTED TO THIS EVENT. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420041 EVOLUTION BILIARY CONTROLLED-RELEASE STENT- UNCOVERED FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD C977905

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R