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

Model Number	M00576640
Medical Device Problem Codes	Use of Device Problem (1670); Positioning Problem (3009)
Health Effect - Clinical Codes	Respiratory Insufficiency (4462); Swelling/ Edema (4577); Insufficient Information (4580)
Date of Event	02/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf patient code e2338 captures the reportable patient complication of swelling/edema.Imdrf patient code e2401 captures the reportable patient complication of desaturation of airway.Impact code f23 is being used to capture the scheduled second placement procedure on (b)(4) 2023.
Event or Problem Description
It was reported to boston scientific corporation on february 27, 2023, that an ultraflex tracheobronchial covered distal stent was to be implanted in the trachea to treat a 5cm benign tracheal stenosis during a bronchoscopy with tracheal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was structured at 1.5 cm and was dilated to 15 mm.During the procedure, the guidewire was introduced into the flexible bronchoscope to survey the airway.The bronchoscope was then removed, and the stent was backloaded over the guidewire.Upon deployment, the ultraflex tracheobronchial stent bunched up in the lma (laryngeal mask airway) and was deployed inside the lma.The ultraflex tracheobronchial stent was removed from the patient together with the lma.Subsequently, edema/ swelling and airway desaturation were observed; therefore, airway re-saturation and decompression was performed.The procedure was not completed, and a new procedure for stent placement was scheduled on (b)(6) 2023.The patient condition after the procedure was expected to fully recover.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf patient code e2338 captures the reportable patient complication of swelling/edema.Imdrf patient code e0743 captures the reportable patient complication of desaturation of airway.Impact code f23 is being used to capture the scheduled second placement procedure on (b)(6) 2023.Block h11: blocks b5 and h6 (patient code and device code) have been corrected.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an ultraflex tracheobronchial covered distal stent was to be implanted in the trachea to treat a 5cm benign tracheal stenosis during a bronchoscopy with tracheal stent placement procedure performed on (b)(6) 2023.The patient's anatomy was structured at 1.5 cm and was dilated to 15 mm.During the procedure, the guidewire was introduced into the flexible bronchoscope to survey the airway.The bronchoscope was then removed, and the stent was backloaded over the guidewire.Upon deployment, the ultraflex tracheobronchial stent bunched up in the lma (laryngeal mask airway) and was deployed inside the lma.The ultraflex tracheobronchial stent was removed from the patient together with the lma.Subsequently, edema/ swelling and airway desaturation were observed; therefore, airway re-saturation and decompression was performed.The procedure was not completed, and a new procedure for stent placement was scheduled on (b)(6) 2023.The patient condition after the procedure was expected to fully recover.Note: it was reported that the ultraflex tracheobronchial stent was to be implanted for a benign tracheal stenosis.Per the instructions for use (ifu), "the ultraflex tracheobronchial stent system is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms." the stent is not indicated for benign tracheal stenosis.

• 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: 16566599
• Report Number: 3005099803-2023-01416
• Device Sequence Number: 20189345
• Product Code: JCT
• UDI-Device Identifier: 08714729842446
• UDI-Public: 08714729842446
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2023

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: 11/16/2024
• Device Model Number: M00576640
• Device Catalogue Number: 7664
• Device Lot Number: 0030557059
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/27/2023
• Supplement Date Received by Manufacturer: 04/26/2023
• Initial Report FDA Received Date: 03/17/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/17/2022
• 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: Female