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

Model Number M00517760

Device Problem Migration (4003)

Patient Problem Fistula (1862)

Event Date 01/09/2024

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.Blocks d4 and h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and the device manufacture dates are unknown.Block e1: the stent placement procedure was performed by dr.(b)(6) and the stent explantation procedure was performed by dr.(b)(6) block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf patient code e2314 captures the reportable patient complication of fistula.Imdrf impact code f23 captures the unexpected intervention to remove the stent.

Event Description

It was reported to boston scientific corporation that an agile esophageal otw fully covered stent was implanted to treat an esophagofistula in the esophagus during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2023.On january 9, 2024, it was confirmed through a lateral chest radiograph that the agile esophageal stent had partially migrated in the distal part of the anatomy.A stent removal procedure was performed on the same day, and the stent was removed from the patient with forceps.A fistula was reported to have been noted on the patient; however, there were no patient complications reported as a result of this event.

• Brand Name: AGILE ESOPHAGEAL OTW
• 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: 18690270
• MDR Text Key: 335186048
• Report Number: 3005099803-2024-00369
• Device Sequence Number: 1
• Product Code: ESW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K211960
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/18/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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