BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AXIOS STENT AND DELIVERY SYSTEM

    MDR report key: 6980102 · Received October 26, 2017

    Report

    Report Number
    3005099803-2017-03138
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    October 4, 2017
    Report Date
    October 4, 2017
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    PCU
    UDI-DI
    08714729904595
    PMA / PMN Number
    K150692
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE COMPLAINANT INDICATED THAT THE DEVICE REMAINS IMPLANTED 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 A HOT AXIOS STENT WAS IMPLANTED IN A TRANSGASTRIC POSITION TO TREAT A PANCREATIC PSEUDOCYST DURING AN ENDOSCOPIC ULTRASOUND (EUS) CYSTGASTROSTOMY PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN SUCCESSFULLY DEPLOYED THE FIRST FLANGE OF THE STENT. HOWEVER, WHEN THE PHYSICIAN ATTEMPTED TO RETRACT THE CATHETER, RESISTANCE WAS ENCOUNTERED AND THE CATHETER WOULD NOT RETRACT. WHEN THE PHYSICIAN AGAIN TRIED TO RETRACT THE CATHETER, THE REMAINDER OF THE STENT PREMATURELY DEPLOYED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY BRIDGING THE FIRST AXIOS STENT WITH A SECOND AXIOS STENT. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759143 AXIOS STENT AND DELIVERY SYSTEM PANCREATIC STENT, COVERED, METALLIC, REMOVABLE PCU BOSTON SCIENTIFIC - GALWAY M00553650 20254330 08714729904595

    Patients

    Seq Age Sex Outcome Treatment
    1