BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED

    MDR report key: 4135609 · Received September 26, 2014

    Report

    Report Number
    3001845648-2014-00176
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    August 4, 2014
    Report Date
    August 28, 2014
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K121430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT MEETS THE CRITERIA OF AN FDA MDR REPORT BASED ON THE ADDITIONAL PROCEDURE TO PLACE AN ADDITIONAL STENT. NO DEVICE MALFUNCTION HAS BEEN REPORTED. FULL COMPLAINT DETAILS AS FOLLOWS: "STUDY (B)(4) EVOLUTION UNCOVERED BILIARY STENT STUDY PT; OCCLUSION OF STUDY STENT DUE TO FOOD IMPACTION: THIS 46 YEAR OLD FEMALE PRESENTED AT THE TIME OF ENROLLMENT WITH A HISTORY OF STAGE 4 PANCREATIC CANCER AND WAS CURRENTLY UNDERGOING CHEMOTHERAPY. TOTAL BILIRUBIN COMPLETED ON (B)(4) 2014 WAS 5.6 MG/DL. ON THE DAY OF THE PROCEDURE ((B)(6) 2014) THE BILIARY STRICTURE MEASURED 1.5 CM AND WAS LOCATED IN THE COMMON BILE DUCT. MILD TORTUOSITY OF THE COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT. A 10 MM X 8 CM ((B)(4)) EVOLUTION BILIARY STENT, COMMON BILE DUCT WAS NOTED. SPHINCTEROTOMY WAS PERFORMED PRIOR TO STENT PLACEMENT. A 10 MM X 8 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, (28 DAYS POST-PROCEDURE) THE PT EXPERIENCED ABDOMINAL PAIN AND FEVER. TOTAL BILIRUBIN COMPLETED ON THE SAME DAY WAS 4.0 MG/DL. THE PT UNDERWENT ERCP WHICH REVEALED OCCLUSION WITHIN THE STUDY STENT DUE TO FOOD IMPACTION. A NON-STUDY STENT (STENT IN STENT) WAS PLACED. IT WAS NOTED THAT A PRE-EXISTING CONDITION CAUSED OR CONTRIBUTED TO THIS EVENT; HOWEVER, NO OTHER INFO WAS PROVIDED. THE SITE MARKED NO TO THE FOLLOWING QUESTION: DID THE DEVICE MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OF PERFORMANCE?" THE DEVICE WAS NOT AVAILABLE TO BE RETURNED FOR EVAL; 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. A REVIEW OF THE MFG RECORDS FOR (B)(4) DEVICE OF LOT C958176 DID NOT REVEAL ANY DISCREPANCIES THAT COULD HAE CONTRIBUTED TO THIS ISSUE. PRIOR TO DISTRIBUTION ALL (B)(4) DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL CHECKS TO ENSURE DEVICE INTEGRITY. FROM THE INFO PROVIDED, IT WAS NOTED THAT A PRE-EXISTING CONDITION CAUSED OR CONTRIBUTED TO THIS EVENT. THE DEVICE DID NOT MALFUNCTION OR DETERIORATE IN CHARACTERISTICS OR PERFORMANCE. THE PT UNDERWENT ERCP WHICH REVEALED OCCLUSION WITHIN THE STUDY STENT DUE TO FOOD IMPACTION. A NON-STUDY STENT (STENT IN STENT) WAS PLACED. THE PT WAS DISCHARGED FROM THE HOSP; HOWEVER, ADMISSION AND DISCHARGE DATES HAVE NOT BEEN PROVIDED. THE CUSTOMER COMPLAINT COULD BE CONFIRMED BASED ON CUSTOMER TESTIMONY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 1

    A 10 MM X 8 CM ((B)(4)) EVOLUTION BILIARY STENT, UNCOVERED WAS PLACED IN PT ON THE (B)(6) 2014. ON (B)(6) 2014 (28 DAYS POST-PROCEDURE) THE PT EXPERIENCED ABDOMINAL PAIN AND FEVER. TOTAL BILIRUBIN COMPLETED ON THE SAME DAY WAS 4.0 MG/DL. THE PT UNDERWENT ERCP WHICH REVEALED OCCLUSION WITHIN THE STUDY STENT DUE TO FOOD IMPACTION. A NON-STUDY STENT (STENT IN STENT) WAS PLACED. THE PT WAS DISCHARGED AND NO FURTHER ADVERSE EFFECTS HAVE BEEN REPORTED AS OCCURRING. THE USER FACILITY INDICATED THAT A PRE-EXISTING CONDITION CAUSED OR CONTRIBUTED TO THIS EVENT; HOWEVER, NO OTHER INFO WAS PROVIDED. THE USER FACILITY HAS ALSO INDICATED THAT THE DEVICE DID NOT MALFUNCTION OR DETERIORATE IN PERFORMANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600215 EVOLUTION BILIARY CONTROLLED-RELEASE STENT - UNCOVERED FGE COOK IRELAND LTD C958176

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention