MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE ESOPHAGEAL; PROSTHESIS, ESOPHAGEAL

Model Number	M00517250
Medical Device Problem Codes	Human-Device Interface Problem (2949); Device Stenosis (4066)
Health Effect - Clinical Codes	Dysphagia/ Odynophagia (1815); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Blocks 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.Block h6: imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted in the middle esophagus to treat a malignant stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.On an unknown date, post stent placement, it was observed that there was an ingrowth on the uncovered part of the stent.The physician noticed that the stent ingrowth occurred much earlier than with the wallflex esophageal stent.Subsequently, another stent was placed and the procedure was completed.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 and h6 (patient codes) have been updated with additional information received on november 17, 2023.Block b3: approximated based on the date the manufacturer became aware of the event.Blocks 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.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted in the middle esophagus to treat a malignant stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.On an unknown date, post stent placement, it was observed that there was an ingrowth on the uncovered part of the stent.The physician noticed that the stent ingrowth occurred much earlier than with the wallflex esophageal stent.Subsequently, another stent was placed and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on november 17, 2023: on an unknown date, post stent placement, the patient presented with dysphagia which prompted the physician to check the stent.A wallflex esophageal stent was placed to complete the procedure.
Additional Manufacturer Narrative
Blocks b5, d4 (model number, lot number, catalog number, expiration date, unique identifier #), d6a, and h4 have been updated with additional information received on january 05, 2024 and january 14, 2024.Block b3: approximated based on the date the manufacturer became aware of the event.Blocks 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.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf device code a0106 captures the reportable event of stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted in the middle esophagus to treat a malignant stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.On an unknown date, post stent placement, it was observed that there was an ingrowth on the uncovered part of the stent.The physician noticed that the stent ingrowth occurred much earlier than with the wallflex esophageal stent.Subsequently, another stent was placed and the procedure was completed.There were no patient complications reported as a result of this event.On an unknown date, post stent placement, the patient presented with dysphagia which prompted the physician to check the stent.A wallflex esophageal stent was placed to complete the procedure.The agile esophageal stent remained implanted.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted in the middle esophagus to treat a malignant stricture during a stent placement procedure performed on an unknown date.The patient's anatomy was tortuous.On an unknown date, post stent placement, it was observed that there was an ingrowth on the uncovered part of the stent.The physician noticed that the stent ingrowth occurred much earlier than with the wallflex esophageal stent.Subsequently, another stent was placed and the procedure was completed.There were no patient complications reported as a result of this event.On an unknown date, post stent placement, the patient presented with dysphagia which prompted the physician to check the stent.A wallflex esophageal stent was placed to complete the procedure.The agile esophageal stent remained implanted.The agile esophageal stent was placed on (b)(6) 2023.On (b)(6) 2023, a wallflex esophageal fully covered stent was placed to complete the procedure.There were no problems reported after the placement of the second stent.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf device code a0106 captures the reportable event of stent obstruction within device.Block h11: block b5 has been corrected based on information received on january 05, 2024.

• Brand Name: AGILE ESOPHAGEAL
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• 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: 18161034
• Report Number: 3005099803-2023-06217
• Device Sequence Number: 15265723
• Product Code: ESW
• UDI-Device Identifier: 08714729972952
• UDI-Public: 08714729972952
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K180144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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,Followup,Followup
• Report Date (Section B): 02/02/2024

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: 06/13/2025
• Device Model Number: M00517250
• Device Catalogue Number: 1725
• Device Lot Number: 0031815193
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 11/17/2023; 01/05/2024; 01/29/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 12/11/2023; 01/26/2024; 02/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• 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