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

Model Number	M00517760
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Imdrf device code a010402 captures the reportable event of stent migration.
Event or Problem 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
• 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: 18695737
• Report Number: 3005099803-2024-00426
• Device Sequence Number: 7205549
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: 00191506006631
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K211960
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2024
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2022
• 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