BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 1081342 · Received July 24, 2008

    Report

    Report Number
    2134265-2008-02079
    Event Type
    Injury
    Date Received
    July 24, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 27, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A RESTENOSIS TREATING PROCEDURE, STENT DISLODGEMENT DIFFICULTIES WERE ENCOUNTERED. THE LESION BEING TREATED WAS RESTENOSIS OF A LESION IN THE INFERIOR BILE DUCT. AN UNSPECIFIED PERCUTANEOUS TRANSHEPATIC CHOLANGIO DRAINAGE CATHETER WAS USED TO VISUALIZE THE LESION, AND THEN AN AMPLATZ SUPER STIFF GUIDE WIRE WAS ADVANCED TO THE SUSPENSORY LIGAMENT OF THE DUODENUM. ANOTHER MFR'S SHEATH WAS ADVANCED ON THE WIRE, HOWEVER, IT KINKED AT THE LOOP IN THE ABDOMINAL CAVITY. THE EXPRESS BILIARY LD STENT DELIVERY SYSTEM (SDS) WAS THEN ADVANCED ON THE GUIDE WIRE WITHOUT A SHEATH. RESISTANCE WAS ENCOUNTERED AT THE LOOP, AND FORCE WAS USED TO ADVANCE IT. THE ADHESION FORMATION WHICH WAS CAUSING THE RESISTANCE BROKE FREE, AND THE EXPRESS BILIARY LD SDS WAS THEN ADVANCED THROUGH THE ABDOMINAL CAVITY. WHEN IT WAS RETRACTED, SEVERE RESISTANCE WAS FELT. THE PHYSICIAN CONFIRMED THAT THE STENT REMAINED IN THE ABDOMINAL CAVITY. A FISTULA WAS THEN CREATED OUTSIDE OF THE BILE DUCT AND BILE DRAINAGE WAS PERFORMED. AN ADDITIONAL INTERVENTION WAS PLANNED A COUPLE OF WEEKS LATER TO IMPLANT ANOTHER STENT THROUGH THE RIGHT HEPATIC DUCT. THE PT REMAINED IN THE HOSP 3 DAYS ON ANTIBIOTIC AND WAS DISCHARGED IN 'GOOD' CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC NA 11336269

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Other TERUMO 7F SHEATH