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

Model Number M00517240

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

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

Event Date 12/08/2023

Event Type  Injury  

Manufacturer Narrative

Blocks d4, h4: the complainant was unable to provide the suspect device 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 partially covered 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 and was not dilated prior to stent placement.On (b)(6) 2023, during a routine follow-up, 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, to restore patency, a wallflex esophageal stent was placed, and the procedure was completed.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Blocks b5, d4 (lot number, expiration date), d6a, h4, h6 (patient codes) have been updated with additional information received on january 05, 2024.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 partially covered 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 and was not dilated prior to stent placement.On october 27, 2023, during a routine follow-up, 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, to restore patency, a wallflex esophageal stent was placed, and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on january 05, 2024.Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer reports # 3005099803-2023-06204 and 3005099803-2024-00099 for the associated device information.On (b)(6) 2023, the first agile esophageal stent was implanted (the subject of mfr.Report # 3005099803-2024-00099); however, on an unknown date, the patient presented with dysphagia which prompted the physician to check the stent.Stent ingrowth was observed and a second agile esophageal stent (the subject of this report) was placed on (b)(6) 2023.Subsequently, on an unknown date, the patient presented again with dysphagia, and stent ingrowth was also observed on the second agile esophageal stent.Consequently, on (b)(6) 2023, a wallflex esophageal stent was placed and the procedure was completed.

Event Description

It was reported to boston scientific corporation that an agile esophageal partially covered 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 and was not dilated prior to stent placement.On (b)(6) 2023, during a routine follow-up, 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, to restore patency, a wallflex esophageal stent was placed, and the procedure was completed.There were no patient complications reported as a result of this event.**additional information received on january 05, 2024** note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer reports # 3005099803-2023-06204 and 3005099803-2024-00099 for the associated device information.On (b)(6) 2023, the first agile esophageal stent was implanted (the subject of mfr.Report # 3005099803-2024-00099); however, on an unknown date, the patient presented with dysphagia which prompted the physician to check the stent.Stent ingrowth was observed and a second agile esophageal stent (the subject of this report) was placed on (b)(6) 2023.Subsequently, on an unknown date, the patient presented again with dysphagia, and stent ingrowth was also observed on the second agile esophageal stent.Consequently, on (b)(6) 2023, a wallflex esophageal stent was placed, and the procedure was completed.Additional information received on february 27, 2024.Note: this report pertains to one of three devices used in the same patient.Refer to manufacturer reports # 3005099803-2024-00099, and 3005099803-2024-01133 for the associated device information.On (b)(6) 2023, the patient experienced dysphagia and was then implanted with the first agile esophageal stent (the subject of mfr.Report # 3005099803-2024-00099).However, on (b)(6) 2023, the patient again experienced dysphagia and the stent was repositioned.On (b)(6) 2023, the patient experienced dysphagia for the third time and a second agile esophageal stent (the subject of this report) was implanted.Subsequently, on (b)(6) 2023, the patient again had dysphagia and a wallflex esophageal stent (the subject of mfr.Report # 3005099803-2024-01133) was implanted.On (b)(6) 2024, the patient again presented with dysphagia and consequently, both the second agile and the wallflex esophageal stents were removed, and a non-boston scientific stent was placed stent-in-stent on the uncovered portion of the first agile esophageal stent.

Manufacturer Narrative

Blocks b3, b5, d6b, and h6 (impact codes and evaluation conclusion codes) have been updated with additional information received on february 27, 2024.Block h6: imdrf patient code e1009 captures the reportable event of dysphagia.Imdrf impact code f2202 is being used to capture the additional endoscopic procedures.Imdrf device code a0106 captures the reportable event of stent obstruction within device.

• 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: 18155469
• MDR Text Key: 328353905
• Report Number: 3005099803-2023-06204
• Device Sequence Number: 1
• Product Code: ESW
• UDI-Device Identifier: 08714729972945
• UDI-Public: 08714729972945
• 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
• Report Date: 03/19/2024

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: M00517240
• Device Catalogue Number: 1724
• Device Lot Number: 0030251667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/16/2023
• Supplement Dates Manufacturer Received: 01/05/2024; 02/27/2024
• Supplement Dates FDA Received: 01/26/2024; 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2022
• 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