BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ULTRAFLEX¿ TRACHEOBRONCHIAL

    MDR report key: 2213484 · Received August 16, 2011

    Report

    Report Number
    3005099803-2011-02742
    Event Type
    Injury
    Date Received
    August 16, 2011
    Date of Event
    July 25, 2011
    Report Date
    July 26, 2011
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    JCT
    PMA / PMN Number
    K012883
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A VISUAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT THE STENT HAD BEEN FULLY DEPLOYED FROM THE DELIVERY SYSTEM. NO ISSUES WERE NOTED WITH THE PROFILE OF THE DEPLOYED STENT. IT WAS NOTED THAT THE SHAFT WAS KINKED AT 73MM PROXIMAL TO THE DISTAL TIP. THE PACKAGING STYLET WAS RETURNED INTACT; HOWEVER, THE BLUE PLASTIC TIP OF THE STYLET WAS ABLE TO BE DETACHED FROM THE METAL PART OF THE STYLET WITH MODERATE FORCE. NO OTHER ISSUES WERE NOTED WITH THE DEVICE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS AT THE TIME OF RELEASE TO DISTRIBUTION. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED BATCH. A LABELING REVIEW WAS PERFORMED AND, FROM THE INFORMATION AVAILABLE, THIS DEVICE WAS USED PER THE DIRECTIONS FOR USE (DFU) / PRODUCT LABEL. THE MOST PROBABLE ROOT CAUSE CLASSIFICATION IS UNDETERMINABLE.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT FAILED TO EXPAND. REPORTED EVENT OF STYLET COMPONENT DETACHED. THE DEVICE HAS BEEN RECEIVED FOR ANALYSIS. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE MID-RIGHT MAIN BRONCHUS. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED AN ULTRAFLEX TRACHEOBRONCHIAL STENT WITH A 2MM STENT LENGTH. THE STENT WAS PLACED WITHOUT ISSUES. HOWEVER, THE PHYSICIAN DETERMINED THAT THE STENT WAS NOT LONG ENOUGH FOR THE LESION. THE PHYSICIAN CONFIRMED THAT THE WRONG SIZE STENT WAS CHOSEN FOR THE ANATOMY AND NO COMPLAINT WAS ALLEGED AGAINST THIS DEVICE. THE STENT WAS LEFT IMPLANTED. THE PHYSICIAN DECIDED TO PLACE A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS MFR REPORT # 3005099803-2011-02742) TELESCOPING WITHIN THE FIRST STENT. WHEN REMOVING THE STYLET FROM THE DISTAL TIP OF THE STENT DELIVERY SYSTEM, THE PLASTIC TIP DETACHED FROM THE METAL PORTION OF THE STYLET. THE METAL STYLET WAS GRASPED AND REMOVED FROM THE STENT SYSTEM. THE STENT SYSTEM WAS THEN INTRODUCED INTO THE PATIENT. THE PHYSICIAN ENCOUNTERED RESISTANCE DURING DEPLOYMENT. THE PHYSICIAN WAS ABLE TO COMPLETELY DEPLOY THE SECOND STENT. HOWEVER, AFTER TWO MINUTES, THE STENT HAD NOT FULLY EXPANDED. THEREFORE, THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WITH A 3MM STENT LENGTH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN ULTRAFLEX TRACHEOBRONCHIAL STENT SYSTEM WAS USED DURING A STENT PLACEMENT PROCEDURE ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD A STRICTURE WITHIN THE MID-RIGHT MAIN BRONCHUS. THE PATIENT ANATOMY WAS NOT NOTED TO BE TORTUOUS AND THE STRICTURE WAS NOT DILATED PRIOR TO STENT PLACEMENT. DURING THE PROCEDURE, THE PHYSICIAN IMPLANTED AN ULTRAFLEX TRACHEOBRONCHIAL STENT WITH A 2MM STENT LENGTH. THE STENT WAS PLACED WITHOUT ISSUES. HOWEVER, THE PHYSICIAN DETERMINED THAT THE STENT WAS NOT LONG ENOUGH FOR THE LESION. THE PHYSICIAN CONFIRMED THAT THE WRONG SIZE STENT WAS CHOOSEN FOR THE ANATOMY AND NO COMPLAINT WAS ALLEGED AGAINST THIS DEVICE. THE STENT WAS LEFT IMPLANTED. THE PHYSICIAN DECIDED TO PLACE A SECOND ULTRAFLEX TRACHEOBRONCHIAL STENT (THE SUBJECT OF THIS MFR. REPORT # 3005099803-2011-02742) TELESCOPING WITHIN THE FIRST STENT. WHEN REMOVING THE STYLET FROM THE DISTAL TIP OF THE STENT DELIVERY SYSTEM, THE PLASTIC TIP DETACHED FROM THE METAL PORTION OF THE STYLET. THE METAL STYLET WAS GRASPED AND REMOVED FROM THE STENT SYSTEM. THE STENT SYSTEM WAS THEN INTRODUCED INTO THE PATIENT. THE PHYSICIAN ENCOUNTERED RESISTANCE DURING DEPLOYMENT. THE PHYSICIAN WAS ABLE TO COMPLETELY DEPLOY THE SECOND STENT. HOWEVER, AFTER TWO MINUTES, THE STENT HAD NOT FULLY EXPANDED. THEREFORE, THE STENT WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER ULTRAFLEX TRACHEOBRONCHIAL STENT WITH A 3MM STENT LENGTH. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ULTRAFLEX¿ TRACHEOBRONCHIAL PROSTHESIS, TRACHEAL, EXPANDABLE JCT BOSTON SCIENTIFIC - GALWAY M00568940 12197267

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention