BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6997517 · Received November 2, 2017

    Report

    Report Number
    3005099803-2017-03289
    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
    UDI-DI
    08714729904595
    PMA / PMN Number
    K150692
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 # 3005099803-2017-03296 PERTAINS TO THE FIRST HOT AXIOS STENT AND DELIVERY SYSTEM AND MANUFACTURER REPORT # 3005099803-2017-03289 PERTAINS TO THE SECOND HOT AXIOS STENT AND DELIVERY SYSTEM. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A HOT AXIOS STENT AND DELIVERY SYSTEM WAS TO BE IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO PLACE THE FIRST AXIOS STENT; HOWEVER, DURING DEPLOYMENT, THE PHYSICIAN DID NOT HAVE THE DEVICE ACCURATELY POSITIONED WITHIN THE CYST. AS A RESULT, THE STENT WAS DEPLOYED IN THE PATIENT'S STOMACH. THE STENT WAS REMOVED WITH A GRASPER, AND THE PROCEDURE WAS CONTINUED WITH A SECOND HOT AXIOS STENT AND DELIVERY SYSTEM. THE SECOND AXIOS STENT WAS ADVANCED INTO THE PSEUDOCYST AND THE FIRST FLANGE WAS DEPLOYED. ACCORDING TO THE COMPLAINANT, VISUALIZATION WAS NOT VERY GOOD. THE SECOND FLANGE OF THE STENT WAS SUCCESSFULLY DEPLOYED OUTSIDE THE CYST; HOWEVER, UPON VISUALIZING THE DEPLOYMENT, IT WAS NOTED THAT THE FIRST FLANGE FAILED TO EXPAND WITHIN THE CYST. THE STENT WAS REMOVED FROM THE PATIENT WITH FORCEPS. THE PHYSICIAN DID NOT HAVE ANY FURTHER AXIOS STENTS AVAILABLE, SO THE PATIENT WAS REFERRED TO INTERVENTIONAL RADIOLOGY FOR TREATMENT/DRAINAGE OF THEIR PSEUDOCYST. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    776212 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553650 0020497187 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention