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

Model Number	M00517460
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal fully covered stent was to be implanted in the esophagus to treat an esophageal stricture due to esophageal cancer during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stent prematurely deployed.The stent was removed using rat tooth forceps and another agile esophageal stent was used to complete the procedure.There were no patient complications as a result of this event.

• Brand Name: AGILE ESOPHAGEAL
• 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: 18399113
• Report Number: 3005099803-2023-06884
• Device Sequence Number: 19526372
• Product Code: ESW
• UDI-Device Identifier: 08714729973089
• UDI-Public: 08714729973089
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K180144
• 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): 12/27/2023

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: 03/28/2025
• Device Model Number: M00517460
• Device Catalogue Number: 1746
• Device Lot Number: 0031327572
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 12/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/29/2023
• 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