BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL

    MDR report key: 18398757 · Received December 27, 2023

    Report

    Report Number
    2124215-2023-70132
    Event Type
    Injury
    Date Received
    December 27, 2023
    Date of Event
    November 22, 2023
    Report Date
    April 1, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF PATIENT CODE E060104 CAPTURES THE REPORTABLE EVENT OF BRADYCARDIA. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF INVASIVE VENTILATION PERFORMED TO ADDRESS THE PATIENT'S COMPLICATIONS.

    Additional Manufacturer Narrative · 0

    BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF STENT PARTIALLY DEPLOYED. IMDRF PATIENT CODE E060104 CAPTURES THE REPORTABLE EVENT OF BRADYCARDIA. IMDRF PATIENT CODE E0726 CAPTURES THE REPORTABLE EVENT OF HYPOXIA. IMDRF IMPACT CODE F23 CAPTURES THE REPORTABLE EVENT OF INVASIVE VENTILATION PERFORMED TO ADDRESS THE PATIENT'S COMPLICATIONS. BLOCK H10: AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT AND DELIVERY SYSTEM WERE RECEIVED FOR ANALYSIS. VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THE STENT PARTIALLY DEPLOYED. FUNCTIONAL TESTING WAS PERFORMED BY PULLING THE FINGER RING, AND NO RESISTANCE WAS FELT. NO OTHER PROBLEMS WERE NOTED TO THE STENT AND DELIVERY SYSTEM. THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED WAS CONFIRMED. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE INVESTIGATION CONCLUDED THAT THE REPORTED EVENT WAS LIKELY DUE TO FACTORS ENCOUNTERED DURING THE PROCEDURE. IT MAY BE THAT LESION CHARACTERISTICS, HANDLING OF THE DEVICE AND THE TECHNIQUE USED BY THE PHYSICIAN, LIMITED THE PERFORMANCE OF THE DEVICE AND CONTRIBUTED TO THE STENT PARTIAL DEPLOYMENT. THEREFORE, A REVIEW AND ANALYSIS OF THE ALL THE AVAILABLE INFORMATION INDICATED THAT THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE. BLOCK H11: BLOCK B5 HAS BEEN CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL DISTAL RELEASE COVERED STENT WAS TO BE IMPLANTED TO THE BRONCHUS FOR THE TREATMENT OF BRONCHIAL STENOSIS DURING A BRONCHIAL STENT IMPLANTATION PROCEDURE PERFORMED ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT WAS ATTEMPTED TO BE DEPLOYED; HOWEVER, THE STENT DID NOT FULLY DEPLOY. THE STENT WAS REMOVED, AND THE PROCEDURE WAS NOT COMPLETED. ON (B)(6) 2023, ANOTHER PROCEDURE IS PLANNED TO IMPLANT ANOTHER STENT. THE PATIENT EXPERIENCED A DECLINE IN HIS HEART RATE AND BLOOD OXYGEN SATURATION AND WAS TREATED WITH INVASIVE VENTILATION TO ADDRESS THE PATIENT'S COMPLICATIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC (BSC) THAT THE REFERENCED 18MM X 60MM ULTRAFLEX TRACHEOBRONCHIAL COVERED DISTAL RELEASE STENT WAS SELECTED TO TREAT A BRONCHIAL STENOSIS IN THE LEFT MAIN BRONCHUS IN A 61- YEAR-OLD MALE PATIENT DURING A STENT IMPLANT PROCEDURE ON (B)(6) 2023. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, STENT DEPLOYMENT WAS ATTEMPTED, HOWEVER, THE STENT WAS UNABLE TO FULLY DEPLOY. IT WAS REPORTED THAT THE WIRE (FINGER RING ON THE STENT DELIVERY SYSTEM) COULD NOT BE PULLED. THE PATIENT THEN EXPERIENCED A DECREASE IN HEART RATE ALONG WITH A DECREASE IN OXYGEN SATURATION. THE STENT WAS WITHDRAWN FROM THE PATIENT, AND ASSISTED VENTILATION WAS PROVIDED TO THE PATIENT WHICH INCREASED THE PATIENT'S HEART RATE AND OXYGEN SATURATION. THE PROCEDURE WAS NOT COMPLETED, AND ANOTHER STENT IMPLANT PROCEDURE IS PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1298719 ULTRAFLEX TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M00564870 0030280217

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention