BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COTTON-LEUNG BILIARY STENT

    MDR report key: 15111753 · Received July 27, 2022

    Report

    Report Number
    3005580113-2022-00079
    Event Type
    Injury
    Date Received
    July 27, 2022
    Date of Event
    January 1, 2002
    Report Date
    July 27, 2022
    Manufacturer
    COOK IRELAND LTD
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Distributor report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    COMMON DEVICE NAME: FGE CATHETER, BILIARY, DIAGNOSTIC - BILIARY STENT - METAL.

    Description of Event or Problem · 0

    LAI 2002, COTTON-LEUNG STENT 10F, 15 CM, 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356070 COTTON-LEUNG BILIARY STENT FGE COOK IRELAND LTD UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention