BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 15083644 · Received July 22, 2022

    Report

    Report Number
    3001845648-2022-00451
    Event Type
    Injury
    Date Received
    July 22, 2022
    Date of Event
    January 1, 2002
    Report Date
    January 26, 2023
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    PMA / PMN Number
    K851962
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS STILL PENDING, A FOLLOW UP MDR WILL BE SUBMITTED TO INCLUDE THE INVESTIGATION CONCLUSIONS.

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: THE 1X CLSO-10-15 DEVICE OF UNKNOWN AND LOT NUMBER INVOLVED IN THIS COMPLAINT WAS NOT AVAILABLE FOR EVALUATION. WITH THE INFORMATION PROVIDED, A DOCUMENT-BASED INVESTIGATION WAS CONDUCTED. LAB EVALUATION: THE DEVICE LAB EVALUATION COULD NOT BE COMPLETED AS THE DEVICE, OR PHOTOGRAPHIC EVIDENCE OF THE DEVICE, WAS NOT RETURNED FOR EVALUATION. DOCUMENT REVIEW: PRIOR TO DISTRIBUTION ALL DEVICES ARE SUBJECTED TO A VISUAL INSPECTION AND FUNCTIONAL INSPECTION TO ENSURE DEVICE INTEGRITY. MANUFACTURING RECORDS REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. HISTORICAL DATA REVIEW: HISTORICAL DATA WAS NOT REVIEWED AS THE LOT NUMBER IS UNKNOWN. IFU & LABEL REVIEW: IS SHOULD BE NOTED THAT MIGRATION IS A KNOWN RISK ASSOCIATED WITH BILIARY STENT PLACEMENT AS PER THE IFU0045-7: ¿THOSE ASSOCIATED WITH BILIARY STENT PLACEMENT INCLUDE, BUT ARE NOT LIMITED TO: TRAUMA TO THE BILIARY TRACT OR DUODENUM, OBSTRUCTION OF THE PANCREATIC DUCT, STENT MIGRATION.¿ THERE IS NO EVIDENCE TO SUGGEST THAT THE CUSTOMER DID NOT FOLLOW THE LABEL OR INSTRUCTIONS FOR USE. IMAGE REVIEW: AN IMAGE WAS NOT RETURNED FOR EVALUATION. ROOT CAUSE REVIEW: A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. HOWEVER, STENT MIGRATION IS A KNOWN POTENTIAL COMPLICATION AS PER IFU0045-7. SUMMARY: THE COMPLAINT IS CONFIRMED BASED ON CUSTOMER TESTIMONY. ACCORDING TO THE MEDICAL ADVISOR, THE ¿LUMINAL¿ PERFORATION IN QUESTION REFERS TO A DUODENAL WALL PERFORATION DUE TO DISTAL STENT MIGRATION. ACCORDING TO THE JOURNAL ARTICLE, THE PATIENT SUFFERED FROM ABDOMINAL PAIN UNTIL THE STENT WAS REMOVED AND THE PERFORATION WAS CLOSED SUCCESSFULLY. COMPLAINTS OF THIS NATURE WILL CONTINUE TO BE MONITORED FOR POTENTIAL EMERGING TRENDS.

    Description of Event or Problem · 0

    LAI 2002, COTTON-LEUNG STENT 10F, 15CM, EUS IN MULTIPLE BILIARY PAPILLOMATOSIS. A 74-YEAR-OLD MAN PRESENTED WITH ABDOMINAL PAIN, JAUNDICE, AND WEIGHT LOSS OF 17 POUNDS OVER A 1-MONTH PERIOD. HIS MEDICAL HISTORY INCLUDED PROSTATE CANCER FOR WHICH HE HAD UNDERGONE RADICAL PROSTATECTOMY. THE PATIENT WAS AFEBRILE. EXAMINATION REVEALED JAUNDICE; A SMOOTH, NONTENDER LIVER EDGE PALPABLE 2 CM BELOW THE RIGHT COSTAL MARGIN; AND NO PALPABLE MASS, STIGMATA OF CHRONIC LIVER DISEASE, OR LYMPHADENOPATHY. SUBSEQUENT ERCP CONFIRMED DUCTAL DILATATION AND DEMONSTRATED FROND-LIKE FILLING DEFECTS EXTENDING FROM THE MID PORTION OF THE EXTRAHEPATIC BILE DUCT INTO THE LEFT HEPATIC DUCT. FORCEPS BIOPSY SPECIMENS WERE OBTAINED; THE LESION SEEMED SOFT AND MOBILE. TO ESTABLISH DRAINAGE, A 15-CM, 10F COTTON-LEUNG BILIARY STENT (WILSON-COOK MEDICAL, INC. (B)(4) WAS PLACED. HISTOPATHOLOGIC INTERPRETATION OF THE BIOPSY SPECIMENS WAS CONSISTENT WITH A PAPILLARY ADENOMA. THE PATIENT WAS SCHEDULED FOR SURGICAL EXPLORATION AND POSSIBLE RESECTION OF THE TUMOR. HOWEVER, 1 DAY AFTER ERCP AN ACUTE ABDOMEN DEVELOPED AND HE UNDERWENT URGENT EXPLORATORY LAPAROTOMY. AT OPERATION, THE ENDOSCOPICALLY PLACED BILIARY STENT WAS FOUND TO HAVE MIGRATED FROM THE BILIARY TREE AND HAD CAUSED A LUMINAL PERFORATION APPROXIMATELY 15 CM DISTAL TO THE MAJOR PAPILLA. THE STENT WAS REMOVED AND THE PERFORATION CLOSED. INTRAOPERATIVE CHOLEDOCHOSCOPY WITH A FLEXIBLE INSTRUMENT DEMONSTRATED A DILATED (2 CM DIAMETER) BILE DUCT FILLED WITH PAPILLARY, FRIABLE TISSUE THAT EXTENDED INTO THE LEFT INTRAHEPATIC DUCTS, WHICH WERE DIFFUSELY CARPETED BY TINY POLYPOID GROWTHS. FILE OPENED TO CAPTURE STENT MIGRATION AND LUMINAL PERFORATION. SURGICAL INTERVENTION REQUIRED.

    Description of Event or Problem · 0

    SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 26JAN2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    560610 COTTON-LEUNG BILIARY STENT FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention