MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX TRACHEOBRONCHIAL; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	M00576650
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device problem code (b)(4).The ultraflex tracheobronchial stent has not been received for analysis.Upon receipt and completion of the device analysis, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the mid trachea to treat a malignant stenosis and tracheoesophageal (te) fistula during a tracheal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the ultraflex tracheobronchial stent was able to be deployed beside the previously implanted non boston scientific esophageal stent.However, the ultraflex tracheobronchial stent was unable to support the lumen and moved out of its target location.The ultraflex tracheobronchial stent was removed from the patient with a flexible forceps and another ultraflex tracheobronchial stent was implanted to complete the procedure.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: photos of the complaint device outside the patient were provided by the complainant and showed the stent was fully deployed and the green retention suture was found broken.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex tracheobronchial covered distal release stent was to be implanted in the mid trachea to treat a malignant stenosis and tracheoesophageal (te) fistula during a tracheal stent placement procedure performed on august 01, 2022.The patient's anatomy was tortuous.During the procedure, the ultraflex tracheobronchial stent was able to be deployed beside the previously implanted non boston scientific esophageal stent.However, the ultraflex tracheobronchial stent was unable to support the lumen and moved out of its target location.The ultraflex tracheobronchial stent was removed from the patient with a flexible forceps and another ultraflex tracheobronchial stent was implanted to complete the procedure.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: photos of the complaint device outside the patient were provided by the complainant and showed the stent was fully deployed and the green retention suture was found broken.
Additional Manufacturer Narrative
Block h6: medical device problem code a1502 captures the reportable event of ultraflex tracheobronchial stent positioning issue.Medical device problem code a0401 captures the reportable event of ultraflex tracheobronchial stent suture break.Block h10: an ultraflex tracheobronchial covered distal release delivery system was received for analysis; the stent was not returned.Visual inspection found the shaft bent in different sections.Media analysis was performed on the photo provided by the complainant and it was observed that the retention suture was detached.No other issues were noted to the delivery system.Media analysis confirmed the reported event of stent suture break; however, the reported event of stent positioning issue could not be confirmed as this occurred during the procedure and is not possible to replicate in the laboratory of analysis.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, stent misplacement is noted within the dfu as a potential adverse event associated with the use of the device.It is likely that the patient's tortuous anatomy could have contributed to the observed event of shaft bent.Furthermore, it is possible that the retention suture was detached during the stent removal procedure.Therefore, review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• Brand Name: ULTRAFLEX TRACHEOBRONCHIAL
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15300390
• Report Number: 3005099803-2022-04633
• Device Sequence Number: 7307736
• Product Code: JCT
• UDI-Device Identifier: 08714729842453
• UDI-Public: 08714729842453
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K141584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/14/2023
• Device Model Number: M00576650
• Device Catalogue Number: 7665
• Device Lot Number: 0027661058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 08/26/2022
• Supplement Report FDA Received Date: 11/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG