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

Model Number	M00517400
Medical Device Problem Codes	Premature Activation (1484); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: the reported healthcare facility is: (b)(6) medical center.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a0406 captures the reportable event of stent material deformation.Imdrf device code a150103 captures the reportable event of stent prematurely deployed.Imdrf impact code f2303 captures the reportable event of administering steroids.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was to be implanted to treat an anastomatic stricture in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2023.During the procedure, the stent prematurely deployed before the distal handle was completely pulled back, which caused the stent to become deformed and migrate into the patient's stomach.The stent was removed, and the physician completed the procedure by administering steroids and using a cre balloon.The patient will be rescheduled for another stent placement 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: 17744275
• Report Number: 3005099803-2023-04860
• Device Sequence Number: 4184785
• Product Code: ESW
• UDI-Device Identifier: 08714729973027
• UDI-Public: 08714729973027
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/14/2023

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: 06/11/2025
• Device Model Number: M00517400
• Device Catalogue Number: 1740
• Device Lot Number: 0031797586
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 09/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/12/2023
• 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