BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX? BILIARY

    MDR report key: 3143471 · Received June 3, 2013

    Report

    Report Number
    3005099803-2013-04509
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    April 25, 2013
    Report Date
    May 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. IT WAS REPORTED THE DEVICE WAS NOT USED PAST ITS EXPIRY DATE. (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSE 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 PRELOADED STENT WAS ORIGINALLY PLACED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE IN THE COMMON BILE DUCT (CBD) DURING A PROCEDURE ON (B)(6) 2013. THERE WERE NO ISSUES DURING THIS PROCEDURE. ACCORDING TO THE COMPLAINANT, ON (B)(6) 2013 THE PHYSICIAN PERFORMED AN ADDITIONAL ERCP AND DURING THIS PROCEDURE, THE STENT MIGRATED AND PERFORATED THE WALL OF THE DUODENUM. HE REPOSITIONED THE STENT AND CLOSED THE PERFORATION WITH ENDO CLIPS. THE PROCEDURE WAS COMPLETED AND THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ON (B)(6) 2013, THE PHYSICIAN DID AN ADDITIONAL ERCP ON THE PATIENT. HE AGAIN PLACED ENDO CLIPS ON THE PERFORATION. IT WAS REPORTED, THE PATIENT WASN'T DRAINING, GOT MORE JAUNDICE, AND HAD A MALIGNANCY; THEREFORE, THE ADVANIX PLASTIC STENT WAS REMOVED AT THIS TIME AND A METAL STENT WAS PLACED TO COMPLETE THE PROCEDURE. IT WAS CONFIRMED THERE WERE NO OTHER ISSUES WITH THE PLASTIC STENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    243651 ADVANIX? BILIARY BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00534350

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Other