BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYMPHONY BILIARY STENT

    MDR report key: 245626 · Received October 22, 1999

    Report

    Report Number
    6000036-1999-00138
    Event Type
    Injury
    Date Received
    October 22, 1999
    Date of Event
    September 14, 1999
    Report Date
    September 22, 1999
    Manufacturer
    MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THIS BILIARY STENT WAS DEPLOYED WITHOUT INCIDENT DURING A TRANSJUGULAR INTRAHEPATIC PORTOSYSTEMIC SHUNT (TIPS) REVISION PROCEDURE. DURING POST-DILATATION OF THE STENT WITH A BOSTON SCIENTIFIC MARSHAL BALLOON DILATATION CATHETER, A WELD ON THE STENT BROKE. UPON DEFLATION OF THE BALLOON, THE BALLOON MATERIAL BECAME LODGED ON THE DETACHED STENT WELD (PLEASE REFERENCE 6000036-1999-00141 FOR THE MARSHAL MDR). THE LARGER PORTION OF THE STENT SUBSEQUENTLY MIGRATED INTO THE ATRIUM AND THE PT EXPERIENCED CARDIAC DYSRHYTHMIA. THE BALLOON AND DETACHED WELD WERE REMOVED VIA THE JUGULAR VEIN. A FEMORAL PUNCTURE WAS MADE FOR RETRIEVAL OF THE STENT FROM THE ATRIUM. ANOTHER MFR'S STENT WAS PLACED WITHOUT FURTHER INCIDENT. THE PT'S CONDITION IS GOOD AND HAS SINCE BEEN DISCHARGED. A PORTION OF THE STENT WAS RECEIVED, EVALUATED AND RETAINED BY THIS MFR. APPROXIMATELY TWO WELDS FROM THE STENT WERE NOT RETURNED FOR EVAL. FOLLOW-UP INDICATED THEY WERE INADVERTENTLY MISPLACED. THE STENT DISPLAYED A FULL LONGITUDINAL BREAK. THE WELDS AND BROKEN WIRE APPEAR TO HAVE BEEN WELDED AT ONE TIME. FOLLOW-UP INDICATED A SHEATH USED IN AN ATTEMPT TO REMOVE THE BALLOON CATHETER FROM THE STENT WELD PROPAGATED FURTHER DAMAGE TO THE STENT. THIS DEVICE WAS USED IN A NON-INDICATED PROCEDURE, A TIPS REVISION PROCEDURE. HOWEVER, BASED ON THE ENGINEERING EVAL, THE CO. IS UNABLE TO DETERMINE THE EXACT CAUSE FOR THIS EVENT. DIRECTIONS FOR USE STATE: "THE SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IS INDICATED FOR USE IN TREATMENT OF BILIARY STRICTURES PRODUCED BY MALIGNANT NEOPLASMS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYMPHONY BILIARY STENT Implant NITINOL BILIARY STENT FGE MEDI-TECH A DIVISION OF BOSTON SCIENTIFIC CORP. NA 1882366

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention 2. SYMPHONY BILIARY STENT,| 3. FLEX FINDER GUIDEWIRE.| 1. COOK FLEXOR SHEATH,