BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX BILIARY STENT

    MDR report key: 2832036 · Received November 14, 2012

    Report

    Report Number
    3005099803-2012-05251
    Event Type
    Injury
    Date Received
    November 14, 2012
    Report Date
    October 19, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE UPN AND LOT NUMBER. THEREFORE, THE EXPIRATION AND MANUFACTURE DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ADVANIX BILIARY STENT WAS REMOVED DURING A SCHEDULED STENT REMOVAL PROCEDURE BY ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) IN THE BILE DUCT. ACCORDING TO THE COMPLAINANT, DURING THE REMOVAL PROCEDURE, THE PHYSICIAN GRABBED THE STENT NEAR THE STENT BARB WITH A SNARE AND THE STENT FOLDED OVER AT THIS PLACE. THE PHYSICIAN THEN ATTEMPTED TO PULL THE STENT THROUGH THE SCOPE. THE PROXIMAL PORTION OF THE STENT, AFTER THE BARB, BROKE OFF IN THE SCOPE AND THE REST OF THE STENT (THE LARGER PORTION) REMAINED IN THE DUCT. THE SMALL PORTION WAS REMOVED AND THE PHYSICIAN WENT BACK IN THROUGH THE SCOPE AND RETRIEVED THE REST OF THE STENT IN ONE PIECE. NOTHING WAS LEFT BEHIND IN THE PATIENT AND NO OTHER ISSUES WERE NOTED TO THE STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

    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