BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM

    MDR report key: 2042550 · Received April 6, 2011

    Report

    Report Number
    3005099803-2011-01158
    Event Type
    Injury
    Date Received
    April 6, 2011
    Date of Event
    March 17, 2011
    Report Date
    March 17, 2011
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE 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). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Additional Manufacturer Narrative · 1

    A VISUAL EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE PROXIMAL END OF THE STENT WAS KINKED NEAR THE RADIO OPAQUE MARKER. THE PROXIMAL BARB OF THE STENT WAS TORN/DETACHED/BROKEN. THE TORN BARB WAS NOT RETURNED FOR EVALUATION. THE PROXIMAL TORN/DETACHED/BROKEN END OF THE STENT WAS DISCOLORED DUE TO RESIDUE PRESENT. 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

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01158 AND 3005099803-2011-01159 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO 10FR X 9CM ADVANIX BILIARY STENTS WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). ON (B)(6), 2011, APPROXIMATELY 2-3 MONTHS AFTER THE INITIAL PROCEDURE, DURING A SCHEDULED STENT REMOVAL PROCEDURE, A SNARE WAS USED TO REMOVE THE STENTS. AS THE STENTS WERE REMOVED, THE PROXIMAL FLAP OF THE BOTH STENTS SEPARATED AND BROKE. THE SCOPE WAS REMOVED AND THE PROXIMAL SECTIONS OF THE STENTS WERE REMOVED FROM THE SCOPE BIOPSY CHANNEL. THE SCOPE WAS REINTRODUCED AND ALL REMAINING STENT FRAGMENTS WERE REMOVED FROM THE DUODENUM WITH A SNARE. NO STENT FRAGMENTS WERE LEFT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE SCHEDULED STENT REMOVAL PROCEDURE.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2011-01159 ADDRESS THESE DEVICES. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO 10FR X 9CM ADVANIX BILIARY STENTS WERE USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT OF A PATIENT (PATIENT AGE, SEX, AND WEIGHT ARE UNKNOWN). ON (B)(6) 2011, APPROXIMATELY (B)(6) AFTER THE INITIAL PROCEDURE, DURING A SCHEDULED STENT REMOVAL PROCEDURE, A SNARE WAS USED TO REMOVE THE STENTS. AS THE STENTS WERE REMOVED, THE PROXIMAL FLAP OF THE BOTH STENTS SEPARATED AND BROKE. THE SCOPE WAS REMOVED AND THE PROXIMAL SECTIONS OF THE STENTS WERE REMOVED FROM THE SCOPE BIOPSY CHANNEL. THE SCOPE WAS REINTRODUCED AND ALL REMAINING STENT FRAGMENTS WERE REMOVED FROM THE DUODENUM WITH A SNARE. NO STENT FRAGMENTS WERE LEFT IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS. THE PATIENT WAS REPORTED TO BE FINE AFTER THE SCHEDULED STENT REMOVAL PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADVANIX¿ BILIARY STENT WITH NAVIFLEX¿ RX DELIVERY SYSTEM BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00533370

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention