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

Model Number	M00576620
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Blocks d4 (lot number and expiration date) and h4 (device manufacture date) have been updated with the additional information received on march 17, 2023.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on january 19, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on january 19, 2023, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a malignant airway obstruction during a bronchial self-expanding metal stent (sems) placement procedure performed on (b)(6) 2023.During the procedure, the ultraflex tracheobronchial was deployed; however, the stent was unable to completely expand, and it moved out of the target anatomy location after deployment.The ultraflex tracheobronchial stent was removed from the patient and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imrdf device code a1502 captures the reportable event of stent positioning issue.Block h10: the ultraflex tracheobronchial covered distal stent and delivery system were received for analysis.Visual inspection revealed that the stent was fully expanded and deployed and that the shaft was kinked.No other issues were noted with the delivery system.Product analysis revealed the shaft was kinked which was most likely due to procedural factors such as lesion characteristics, handling of the device, or the techniques used by the user.However, product analysis did not confirm the reported device malfunction of stent failed to expand as the stent was returned fully deployed and expanded.The reported failure of stent positioning issue cannot also be confirmed because this happened during the procedure and is not possible to replicate in the laboratory for analysis.There is no indication of what the customer reported because the stent was returned completely expanded.Therefore, review and analysis of all available information indicated that the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 16330031
• Report Number: 3005099803-2023-00480
• Device Sequence Number: 6835394
• Product Code: JCT
• UDI-Device Identifier: 08714729842422
• UDI-Public: 08714729842422
• 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,Followup
• Report Date (Section B): 04/19/2023

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: 02/11/2023
• Device Model Number: M00576620
• Device Catalogue Number: 7662
• Device Lot Number: 0026791767
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/19/2023
• Supplement Date Received by Manufacturer: 03/17/2023; 03/29/2023
• Initial Report FDA Received Date: 02/08/2023
• Supplement Report FDA Received Date: 03/29/2023; 04/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2021
• 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 Sex: Unknown