BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL

    MDR report key: 24422595 · Received February 23, 2026

    Report

    Report Number
    3005099803-2026-00685
    Event Type
    Injury
    Date Received
    February 23, 2026
    Date of Event
    January 8, 2026
    Report Date
    March 24, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    UDI-DI
    08714729646082
    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 E1: (B)(6) INITIAL REPORTER FACILITY NAME EXCEEDED CHARACTER LIMIT FOR THE DESIGNATED FIELD. BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF STENT UNRAVELED MATERIAL. BLOCK H11: THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE DOCUMENTATION PROVIDED INCLUDES PHOTOGRAPHS OF THE STENT. A MEDIA ANALYSIS WAS PERFORMED WHERE IT CAN BE OBSERVED THAT THE STENT WAS UNRAVELED. MEDIA ANALYSIS CONFIRMED THE REPORTED EVENT OF STENT UNRAVELED MATERIAL AS IT WAS OBSERVED ON DOCUMENTATION PROVIDED THAT THE STENT UNRAVELED. HOWEVER, WITHOUT PROPER EVALUATION OF THE DEVICE IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT CONTRIBUTED TO THE EVENT. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT WAS RELATED TO THE PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE.

    Additional Manufacturer Narrative · 0

    (B)(6). BLOCK H6: IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF STENT UNRAVELED MATERIAL. BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION THAT WAS RECEIVED ON FEBRUARY 24, 2026. BLOCK H11: THE ULTRAFLEX TRACHEOBRONCHIAL STENT WAS NOT RETURNED FOR EVALUATION. THEREFORE, PRODUCT ANALYSIS COULD NOT BE PERFORMED. HOWEVER, THE DOCUMENTATION PROVIDED INCLUDES PHOTOGRAPHS OF THE STENT. A MEDIA ANALYSIS WAS PERFORMED WHERE IT CAN BE OBSERVED THAT THE STENT WAS UNRAVELED. A RISK REVIEW WAS COMPLETED AND CONFIRMED THAT THE EVENTS OF STENT UNRAVELED MATERIAL AND ADDITIONAL DEVICE REQUIRED WERE DEFINED IN THE RISK DOCUMENTATION AND ARE DOCUMENTED ACCORDINGLY. THESE EVENT TYPES HAVE BEEN ACCOUNTED FOR DURING PRODUCT RISK ANALYSIS TO SUPPORT ACCEPTABLE RISK BENEFIT FOR THE PRODUCT. MEDIA ANALYSIS CONFIRMED THE REPORTED EVENT OF STENT UNRAVELED MATERIAL AS IT WAS OBSERVED ON DOCUMENTATION PROVIDED THAT THE STENT UNRAVELED. HOWEVER, WITHOUT PROPER EVALUATION OF THE DEVICE IT REMAINS UNKNOWN THE MOST PROBABLE CAUSES THAT CONTRIBUTED TO THE EVENT. THERE IS NOT ENOUGH EVIDENCE TO DETERMINE IF THE REPORTED EVENT WAS RELATED TO THE PROCEDURAL FACTORS SUCH AS LESION CHARACTERISTICS, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN. TAKING ALL AVAILABLE INFORMATION INTO CONSIDERATION, THE MOST PROBABLE CAUSE OF THE REPORTED EVENT IS ADVERSE EVENT RELATED TO PROCEDURE. FOR THE EVENTS CANCELLED/RESCHEDULED - POST SEDATION/SEDATION UNKNOWN AND ADDITIONAL DEVICE REQUIRED CANNOT BE CONFIRMED BECAUSE IT HAPPENED DURING THE PROCEDURE AND THERE IS NOT AN OBJECTIVE EVIDENCE OR DESCRIPTIVE CONDITIONS TO ESTABLISH THE CAUSE OF THE REPORTED EVENTS. FOR THIS REASON, IT WILL BE CLASSIFIED AS CAUSE NOT ESTABLISHED.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED TO THE LUNGS TO TREAT AN AIRWAY STENOSIS CAUSED BY CANCER DURING AN ENDOSCOPIC IMPLANTATION UNDER BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, AFTER THE STENT WAS DEPLOYED, WHEN THE POSITION OF THE DISTAL END OF KNOT WAS SLIGHTLY ADJUSTED, THE STENT KNOT WAS LOOSENED AND FRACTURED. DUE TO THIS, THE STENT PLACEMENT FAILED. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS TO BE IMPLANTED TO THE LUNGS TO TREAT AN AIRWAY STENOSIS CAUSED BY CANCER DURING AN ENDOSCOPIC IMPLANTATION UNDER BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2026. THE ANATOMY OF THE PATIENT WAS TORTUROUS AND WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING PROCEDURE, AFTER THE STENT WAS DEPLOYED, WHEN THE POSITION OF THE DISTAL END OF KNOT WAS SLIGHTLY ADJUSTED, THE STENT KNOT WAS LOOSENED AND FRACTURED. DUE TO THIS, THE STENT PLACEMENT FAILED. THE STENT WAS THEN REMOVED USING BIOPSY FORCEPS. THE PROCEDURE WAS NOT COMPLETED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE PROCEDURE. THERE WAS NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. ADDITIONAL INFORMATION RECEIVED ON FEBRUARY 24, 2026: IT WAS REPORTED THAT AFTER THE PHYSICIAN TREATED THE LOCAL LESION TISSUE, THERE WAS NO STENT PLACED AGAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    273580 ULTRAFLEX TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M00564770 0037785693 08714729646082

    Patients

    Seq Age Sex Outcome Treatment
    1