BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANIX¿ BILIARY

    MDR report key: 2901981 · Received January 8, 2013

    Report

    Report Number
    3005099803-2013-00002
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    December 17, 2012
    Report Date
    December 17, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    FGE
    PMA / PMN Number
    K101314
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REPORTED TO BE OVER 18 YEARS OLD. (B)(4) THE REPORTED EVENT OF STENT UNABLE TO BE REMOVED FROM PATIENT ANATOMY DURING PROCEDURE. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT IS STILL IMPLANTED; 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 USED DURING AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE IN THE COMMON BILE DUCT PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER THE STENT WAS DEPLOYED THE PHYSICIAN FELT THE STENT WAS TOO LARGE AND DECIDED TO REPLACE IT WITH A SMALLER ONE. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT BY THE PROXIMAL BARB WITH FORCEPS(MODEL UNKNOWN) AND A SNARE(MODEL UNKNOWN). THE STENT IMBEDDED IN THE DUCT AS THEY WERE TRYING TO PULL IT OUT AND WAS UNABLE TO BE REMOVED. THE DISTAL FLANGE BENT DURING REMOVAL AND CAUGHT IN THE COMMON BILE DUCT. NO PERFORATION OR DAMAGE WAS NOTED TO THE PATIENT ANATOMY. THE PATIENT WAS REFERRED TO ANOTHER HOSPITAL FOR REMOVAL OF THE STENT. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE OK. SEVERAL ATTEMPTS HAVE BEEN MADE TO OBTAIN FURTHER INFORMATION REGARDING THE STENT REMOVAL, HOWEVER NO FURTHER INFORMATION IS AVAILABLE FROM EITHER HOSPITAL AND IT IS UNKNOWN WHETHER THE STENT HAS SINCE BEEN REMOVED. IF ANY INFORMATION IS RECEIVED A SUPPLEMENTAL MDR WILL BE FILED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9014 ADVANIX¿ BILIARY BILIARY CATHETERS AND ACCESSORIES FGE BOSTON SCIENTIFIC - SPENCER M00533370 14163906

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention