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

Model Number M00517760

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/25/2023

Event Type  Injury  

Manufacturer Narrative

Imdrf device code a010402 captures the reportable event of stent migration.

Event Description

It was reported to boston scientific corporation that an agile esophageal fully covered stent was implanted in the distal esophagus to treat a 7cm malignant stenosis during an upper gastrointestinal endoscopy procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.The stent was able to be deployed successfully.On april 25, 2023, during a routine follow-up, a computed tomography (ct) scan was performed, and it was noted that the stent migrated.The stent was removed using forceps.The patient's indication was resolved at the time of migration.There were no patient complications 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: 18695737
• MDR Text Key: 335255765
• Report Number: 3005099803-2024-00426
• 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
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2024
• Device Model Number: M00517760
• Device Catalogue Number: 1776
• Device Lot Number: 0029077442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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