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

Model Number	M00513710
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Pneumonia (2011)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, it was reported that the device was not used past expiry date.Literature source: takashima, m., toba, h., yamamoto, k., sakamoto, s., miyamoto, n., matsumoto, o., hebei, n., yuki, k., yoshida, m., takizawa, h., kondo, k., tankuro, a.Case study on airway stent placement for emergency airway due to advanced esophageal cancer.44th annual conference of the japan society for respiratory endoscopy.Oral session 40-3.(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
Boston scientific became aware of an event involving an ultraflex esophageal ng distal release uncovered stent through the article "case study on airway stent placement for emergency airway due to advanced esophageal cancer" by dr.Mika takashima, et al.According to the literature, an ultraflex esophageal ng distal release uncovered stent was implanted in the left main bronchus to treat a respiratory tract stenosis due to advanced esophageal cancer during a stent placement procedure performed between 2019 and 2020.On an unknown date, 1300 days after stent placement, it was noted that the stent gradually moved to the central side of the bronchus.Reportedly, pneumonia was observed due to stubborn cough and sputum discharged difficulty.The stent was removed from the patient.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
Event or Problem Description
Boston scientific became aware of an event involving an ultraflex esophageal ng distal release uncovered stent through the article "case study on airway stent placement for emergency airway due to advanced esophageal cancer" by dr.Mika takashima, et al.According to the literature, an ultraflex esophageal ng distal release uncovered stent was implanted in the left main bronchus to treat a respiratory tract stenosis due to advanced esophageal cancer during a stent placement procedure performed between 2019 and 2020.On an unknown date, 1300 days after stent placement, it was noted that the stent gradually moved to the central side of the bronchus.Reportedly, pneumonia was observed due to stubborn cough and sputum discharged difficulty.The stent was removed from the patient.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.**additional information received on march 18, 2022** an ultraflex tracheobronchial stent was implanted.
Additional Manufacturer Narrative
Blocks b5, d1, d2, d4 (model number, catalog number, udi) and g4 (premarket/ 510(k)#) have been updated with additional information received on march 18, 2022.Block b3: approximated based on the date the manufacturer became aware of the event.Block d4, h4: the complainant was unable to provide the suspect device upn and lot number; therefore, the lot expiration and device manufacture dates are unknown.However, it was reported that the device was not used past expiry date.Block g2: literature source: takashima, m., toba, h., yamamoto, k., sakamoto, s., miyamoto, n., matsumoto, o., hebei, n., yuki, k., yoshida, m., takizawa, h., kondo, k., tankuro, a.Case study on airway stent placement for emergency airway due to advanced esophageal cancer.44th annual conference of the japan society for respiratory endoscopy.Oral session 40-3.Block h6: patient code e0733 captures the reportable patient issue of pneumonia.Medical device problem code a010402 captures the reportable event of stent migration.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• 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: 12347773
• Report Number: 3005099803-2021-04273
• Device Sequence Number: 14750020
• Product Code: JCT
• UDI-Device Identifier: 08714729716136
• UDI-Public: 08714729716136
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K012883
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2022
• 2 Devices were Involved in the Event: 1 2

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 Model Number: M00513710
• Device Catalogue Number: 1371
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 08/20/2021
• Supplement Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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