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

Model Number M00517250

Device Problems Human-Device Interface Problem (2949); Device Stenosis (4066)

Patient Problems Dysphagia/ Odynophagia (1815); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/01/2023

Event Type  Injury  

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 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.

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 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.

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 328416519
• Report Number: 3005099803-2023-06217
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729972952
• UDI-Public: 08714729972952
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: K180144
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/17/2023
• Supplement Dates Manufacturer Received: 11/17/2023; 01/05/2024; 01/29/2024
• Supplement Dates FDA Received: 12/11/2023; 01/26/2024; 02/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention