BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6997504 · Received November 2, 2017

    Report

    Report Number
    3005099803-2017-03231
    Event Type
    Injury
    Date Received
    November 2, 2017
    Date of Event
    October 9, 2017
    Report Date
    October 9, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    PCU
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT'S EXACT AGE IS UNKNOWN; HOWEVER IT WAS REPORTED THAT THE PATIENT WAS OVER THE AGE OF 18. THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED OF 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 MDR WILL BE FILED.

    Description of Event or Problem · 1

    NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED DURING THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2017-03231 PERTAINS TO THE FIRST HOT AXIOS STENT AND DELIVERY SYSTEM AND MANUFACTURER REPORT # 3005099803-2017-03232 PERTAINS TO THE SECOND HOT AXIOS STENT AND DELIVERY SYSTEM. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT WAS TO BE IMPLANTED TRANSDUODENAL TO THE COMMON BILE DUCT DURING AN INPATIENT ENDOSCOPIC ULTRASOUND (EUS)-GUIDED CHOLEDOCHODUODENOSTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE AXIOS DELIVERY SYSTEM WAS BACKLOADED OVER A GUIDEWIRE AND ADVANCED USING BOTH EUS AND FLUOROSCOPY. THE PHYSICIAN SUCCESSFULLY APPLIED CAUTERY TO THE DELIVERY SYSTEM TO ADVANCE IT THROUGH THE DUODENUM AND INTO THE COMMON BILE DUCT. THE PHYSICIAN THEN HAD TROUBLE ASCERTAINING THE REMAINING DISTANCE TO THE BILE DUCT FROM THE DUODENAL PUNCTURE. ACCORDING TO THE PHYSICIAN, THE PATIENT HAD A LOW CYSTIC DUCT AND DIFFICULT ANATOMY, WHICH CONTRIBUTED TO THE DIFFICULTY WITH POSITIONING. THE PHYSICIAN THEN DEPLOYED THE FIRST FLANGE OF THE STENT UNDER EUS VIEW; HOWEVER, AFTER SWITCHING TO ENDOSCOPIC VIEW, IT WAS NOTED THAT THE FIRST FLANGE HAD DEPLOYED INSIDE THE DUODENUM. THE AXIOS STENT WAS REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS CONTINUED WITH A SECOND HOT AXIOS STENT AND DELIVERY SYSTEM; HOWEVER, THE SAME ISSUE OCCURRED. THE SECOND AXIOS STENT WAS ALSO REMOVED FROM THE PATIENT PARTIALLY DEPLOYED ON THE DELIVERY SYSTEM. THE PROCEDURE WAS THEN ABORTED, AS THE PATIENT'S BILE WAS DRAINING THROUGH THE TRANSDUODENAL AXIOS PUNCTURE. THE PHYSICIAN SUSPECTED THAT THE PATIENT'S BILIRUBIN LEVELS WOULD DROP AS A RESULT OF THE BILE DRAINAGE, SO THE PATIENT WAS MONITORED TO DETERMINE WHETHER ANY FURTHER TREATMENT WAS NEEDED. THE PATIENT'S BILIRUBIN LEVELS BEGAN TO ELEVATE AGAIN, SO ON (B)(6) 2017, THE PATIENT UNDERWENT AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP), DURING WHICH A WALLFLEX BILIARY FULLY COVERED STENT WAS IMPLANTED IN THE BILE DUCT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776072 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553530 20687020

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention