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

Model Number	M00576560
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/17/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2022, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a 2/2.5cm malignant tracheal stenosis during a metal stenting procedure performed on (b)(6), 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the stent deformed due to the pressure of the stricture and moved out of its position distally.The stent was removed using forceps and another ultraflex tracheobronchial stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a1502 captures the reportable event of stent positioning issue.Block h10: an ultraflex tracheobronchial delivery system was received for analysis; the stent was not returned.Visual inspection was performed, and no damages were found to the delivery system.The reported event of stent material deformation was not confirmed; the stent was not returned.The reported event of stent positioning issue could not be confirmed; the problem occurred during the procedure, and it is not possible to replicate the problem in the laboratory of analysis.There is not enough evidence to determine the most probable cause of stent positioning issue and stent material deformation.Additionally, without proper evaluation of the stent, it remains unknown the most probable cause that contributed to the event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, the reported events of stent material deformation and stent positioning issue were defined in the risk documentation.Block h11: block d4 (catalogue number) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on november 17, 2022, that an ultraflex tracheobronchial covered distal release stent was to be implanted to treat a 2/2.5cm malignant tracheal stenosis during a metal stenting procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was fully deployed; however, the stent deformed due to the pressure of the stricture and moved out of its position distally.The stent was removed using forceps and another ultraflex tracheobronchial stent was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 15916554
• Report Number: 3005099803-2022-07201
• Device Sequence Number: 15086988
• Product Code: JCT
• UDI-Device Identifier: 08714729842361
• UDI-Public: 08714729842361
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 06/17/2023
• Device Model Number: M00576560
• Device Catalogue Number: 7656
• Device Lot Number: 0027508697
• 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: 11/17/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/05/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2021
• 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: 55 YR
• Patient Sex: Male