BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6990700 · Received October 31, 2017

    Report

    Report Number
    3005099803-2017-03155
    Event Type
    Injury
    Date Received
    October 31, 2017
    Date of Event
    September 21, 2017
    Report Date
    October 5, 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

    (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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN AXIOS STENT WAS TO BE IMPLANTED TRANSDUODENAL TO THE COMMON BILE DUCT DURING AN ENDOSCOPIC ULTRASOUND (EUS)-GUIDED BILIARY DRAINAGE PROCEDURE ON (B)(6) 2017. REPORTEDLY, THE PATIENT HAD PANCREATIC CANCER (LIKELY PANCREATIC ADENOCARCINOMA, LOCALLY ADVANCED) AND AN OBSTRUCTED DUODENUM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, EUS AND FLUOROSCOPY WERE USED AND THE SCOPE WAS IN A VERY TORTUOUS AND DIFFICULT POSITION TO ACCESS THE BILE DUCT. THE PHYSICIAN USED A GUIDEWIRE DURING THE CASE AND WAS UNSURE OF ITS ACCURATE POSITION. AFTER DEPLOYING THE AXIOS STENT, THE PHYSICIAN REALIZED THAT IT HAD BEEN DEPLOYED IN THE INCORRECT POSITION, WITH ONE FLANGE DEPLOYED IN THE BILE DUCT AND ONE FLANGE DEPLOYED IN THE SPACE BETWEEN THE DUODENAL WALL AND THE WALL OF THE BILE DUCT. THE PATIENT WAS TAKEN TO SURGERY, WHERE THEY UNDERWENT A LAPAROSCOPIC CHOLECYSTECTOMY AND EXPLORATORY LAPAROSCOPY. THE PHYSICIAN REPORTED THAT THE AIM OF THE LAPAROSCOPIC CHOLECYSTECTOMY WAS TO ATTEMPT TO PASS A TRANSCYSTIC STENT TO SEAL THE AXIOS PUNCTURE SITE IN THE COMMON BILE DUCT WALL. THE STENT WAS REMOVED FROM THE PATIENT DURING THE LAPAROSCOPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770119 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553520 0020649762

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR Required Intervention