BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ULTRAFLEX TRACHEOBRONCHIAL

    MDR report key: 18996786 · Received March 28, 2024

    Report

    Report Number
    3005099803-2024-01283
    Event Type
    Malfunction
    Date Received
    March 28, 2024
    Date of Event
    March 6, 2024
    Report Date
    June 13, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    JCT
    PMA / PMN Number
    K012883
    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 PARTIALLY DEPLOYED ULTRAFLEX TRACHEOBRONCHIAL STENT. IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF STENT UNRAVELED.

    Additional Manufacturer Narrative · 0

    BLOCK B5 HAS BEEN UPDATED WITH THE ADDITIONAL INFORMATION RECEIVED ON JUNE 4, 2024. BLOCK H6: IMDRF DEVICE CODE A15 CAPTURES THE REPORTABLE EVENT OF PARTIALLY DEPLOYED ULTRAFLEX TRACHEOBRONCHIAL STENT. IMDRF DEVICE CODE A040508 CAPTURES THE REPORTABLE EVENT OF STENT UNRAVELED. BLOCK H11: AN ULTRAFLEX TRACHEOBRONCHIAL STENT WAS RECEIVED FOR ANALYSIS; THE DELIVERY SYSTEM WAS NOT RETURNED. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND THE STENT WAS DEPLOYED, FULLY EXPANDED AND UNRAVELED. MEDIA ANALYSIS CONFIRMED THAT THE STENT WAS UNRAVELED. NO OTHER DAMAGES WERE NOTED TO THE DEVICE. THE REPORTED EVENT OF STENT PARTIALLY DEPLOYED, AND STENT DEPLOYMENT SUTURE BREAK COULD NOT BE CONFIRMED AS THE DELIVERY SYSTEM WAS NOT RETURNED. HOWEVER, THE REPORTED EVENT OF STENT UNRAVELED WAS CONFIRMED. THE DAMAGE NOTED TO THE STENT WAS MOST LIKELY DUE TO PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE SUCH AS CHARACTERISTICS OF THE LESION, HANDLING OF THE DEVICE, THE TECHNIQUE USED BY THE PHYSICIAN, AND THE AMOUNT OF FORCE APPLIED TO THE DEVICE DURING DEPLOYMENT COULD HAVE RESULTED TO STENT UNRAVELED MATERIAL. THEREFORE, A REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE CAUSE IS ADVERSE EVENT RELATED TO PROCEDURE.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS TO BE IMPLANTED TO TREAT A MAIN TRACHEAL STENOSIS DURING A TRANSBRONCHOSCOPIC WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT FULLY DEPLOY. THE PHYSICIAN ADJUSTED THE POSITION OF THE STENT, BUT THE STENT BECAME STRETCHED. THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC BIOPSY FORCEPS, BUT THE BIOPSY FORCEPS GOT ENTANGLED WITH THE STENT. THE STENT WAS REMOVED FROM THE PATIENT TOGETHER WITH THE DELIVERY SYSTEM AND BIOPSY FORCEPS. OUTSIDE THE PATIENT, THE PHYSICIAN CUT THE STENT OFF AS IT WAS ENTANGLED WITH THE BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT WAS OUTSIDE THE PATIENT, UNRAVELED AND WAS FULLY DEPLOYED OFF FROM THE DELIVERY SYSTEM.

    Description of Event or Problem · 0

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL COVERED STENT WAS TO BE IMPLANTED TO TREAT A MAIN TRACHEAL STENOSIS DURING A TRANSBRONCHOSCOPIC WITH STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2024. THE PATIENT'S ANATOMY WAS DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE STENT DID NOT FULLY DEPLOY. THE PHYSICIAN ADJUSTED THE POSITION OF THE STENT, BUT THE STENT BECAME STRETCHED. THE PHYSICIAN USED A NON-BOSTON SCIENTIFIC BIOPSY FORCEPS, BUT THE BIOPSY FORCEPS GOT ENTANGLED WITH THE STENT. THE STENT WAS REMOVED FROM THE PATIENT TOGETHER WITH THE DELIVERY SYSTEM AND BIOPSY FORCEPS. OUTSIDE THE PATIENT, THE PHYSICIAN CUT THE STENT OFF AS IT WAS ENTANGLED WITH THE BIOPSY FORCEPS. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION FOLLOWING THE PROCEDURE WAS REPORTED TO BE STABLE. NOTE: A PHOTO OF THE COMPLAINT DEVICE WAS PROVIDED BY THE COMPLAINANT AND SHOWED THE STENT WAS OUTSIDE THE PATIENT, UNRAVELED AND WAS FULLY DEPLOYED OFF FROM THE DELIVERY SYSTEM. ADDITIONAL INFORMATION RECEIVED ON JUNE 04, 2024: IT WAS REPORTED THAT THE PHYSICIAN DEPLOYED THE STENT OUTSIDE THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    487549 ULTRAFLEX TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC CORPORATION M00564870 0031469589

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male