BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 2071724 · Received April 28, 2011

    Report

    Report Number
    3005099803-2011-01334
    Event Type
    Injury
    Date Received
    April 28, 2011
    Report Date
    April 4, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S EXACT AGE IS UNKNOWN, BUT IS REPORTEDLY OVER 18 YEARS. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE UPN AND LOT NUMBER; THEREFORE, THE DEVICE MANUFACTURE DATE AND EXPIRATION DATE ARE UNKNOWN. ALTHOUGH THE LOT NUMBER IS UNKNOWN, THE COMPLAINANT REPORTED THAT THE DEVICE WAS NOT USED PAST THE EXPIRATION DATE. (B)(4) - THERAPY/NON-SURGICAL TREATMENT, ADDITIONAL. (B)(4) - THE ISSUE OF STENT BROKEN. THE DEVICE HAS BEEN RECEIVED; HOWEVER, THE EVALUATION HAS NOT YET BEEN COMPLETED. IF THERE IS ANY FURTHER RELEVANT INFORMATION, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED, THE PROXIMAL END OF THE STENT WAS KINKED CLOSE TO THE RADIO OPAQUE MARKER. THE PROXIMAL BARB WAS TORN/RIPPED/DETACHED FROM THE STENT. OPERATIONAL/PROCEDURAL FACTORS LIKELY CAUSED THE PROXIMAL BARB OF THE STENT TO TEAR/BREAK/DETACH INADVERTENTLY WHEN THE STENT WAS PULLED OUT WITH THE SNARE. BASED ON THE CONDITION OF THE DEVICE AND THE DETAILS OF THE EVENT, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS OPERATIONAL CONTEXT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE SCHEDULED STENT REMOVAL PROCEDURE (STENT REMOVAL EVENT DATE IS UNKNOWN), THE STENT BROKE AS IT WAS BEING WITHDRAWN FROM THE DUCT WITH A 13MM CAPTIVATOR SNARE. ALL STENT FRAGMENTS WERE REMOVED FROM THE PATIENT. THE STENT REMOVAL PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN FINE AFTER THE PROCEDURE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). DURING THE SCHEDULED STENT REMOVAL PROCEDURE (STENT REMOVAL EVENT DATE IS UNKNOWN), THE STENT BROKE AS IT WAS BEING WITHDRAWN FROM THE DUCT WITH A 13MM CAPTIVATOR SNARE. ALL STENT FRAGMENTS WERE REMOVED FROM THE PATIENT. THE STENT REMOVAL PROCEDURE WAS COMPLETED WITH NO REPORTED PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE IN FINE AFTER THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX BILIARY STENT BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER UNK686

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention