BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY BILIARY STENT

    MDR report key: 262377 · Received February 14, 2000

    Report

    Report Number
    6000036-2000-00020
    Event Type
    Injury
    Date Received
    February 14, 2000
    Date of Event
    January 20, 2000
    Report Date
    January 21, 2000
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS BILIARY STENT WAS PLACED AT THE ILIAC VEIN BIFURCATION DURING A BILATERAL STENT PLACEMENT PROCEDURE. IT WAS INDICATED THIS STENT IMMEDIATELY MIGRATED TO THE AORTA. AN ATTEMPT TO RETRIEVE THE STENT WAS UNSUCCESSFUL. THE PT WAS TRANSFERRED TO ANOTHER FACILITY FOR SUCCESSFUL SURGICAL REMOVAL OF THE STENT. THE PT'S CONDITION IS GOOD. FOLLOW-UP REVEALED THE TRIGGER MECHANISM OF THIS DEVICE INCORRECTLY IDENTIFIED THE STENT AS A 12MM-40MM. HOWEVER, THE PACKAGE AND POUCH LABELING CORRECTLY IDENTIFIED THE STENT AS A 12MM-20MM. THE PHYSICIAN WAS AWARE OF THIS DISCREPANCY PRIOR TO PLACING THE STENT AND MEASURED THE STENT TO CONFIRM THE SIZE WAS A 20MM. PHYSICIAN PREFERRED TO PLACE A LONGER STENT, BUT DID NOT HAVE ANY IN STOCK, AND MADE THE DECISION TO PLACE THE 20MM STENT. PHYSICIAN DOES NOT ATTRIBUTE THIS EVENT TO THE HANDLE LABEL DISCREPANCY, BUT RATHER THE FACT THAT A LONGER STENT WAS NEEDED IN THIS SITUATION. THE USER FACILITY WILL NOT RELEASE THIS DEVICE FOR EVAL. THEREFORE, NO FAILURE ANALYSIS IS AVAILABLE. DIRECTIONS FOR USE STATE: "THE SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IS INDICATED FOR USE IN TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASM...DILATE THE STRICTURE AS NECESSARY WITH A BALLOON DILATATION CATHETER USING CONVENTIONAL TECHNIQUE." SAME CASE AS MFR #6000036-2000-00021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY BILIARY STENT NITINOL BILIARY STENT FGE MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA 2013474

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention