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

Model Number	M00517780
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact date of birth is unknown; however, it was reported that he was born in 1947.Block a4: patient's weight: 85.3 kilograms - reported here as it exceeded the maximum character limit for the designated field.Block g4: premarket 510(k): k211960, k233837 - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code a010402 is being used to capture the reportable event of stent migration.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal over-the-wire stent was implanted in the esophagus to treat a malignant-appearing, intrinsic, moderate ulcerated stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.On (b)(6) 2024, complete proximal stent migration occurred.Reportedly, the stricture was not resolved.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block a1: (b)(6) patient's identifier has been updated.Block a2: patient's exact date of birth is unknown; however, it was reported that he was born in 1947.Block a4: patient's weight: 85.3 kilograms - reported here as it exceeded the maximum character limit for the designated field.Block g4: premarket 510(k): k211960, k233837 - reported here as it exceeded the maximum character limit for the designated field.Block h6: imdrf device code a010402 is being used to capture the reportable event of stent migration.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal over-the-wire stent was implanted in the esophagus to treat a malignant-appearing, intrinsic, moderate ulcerated stenosis during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2024.On (b)(6) 2024, complete proximal stent migration occurred.Reportedly, the stricture was not resolved.No patient complications were reported 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: 21020784
• Report Number: 3005099803-2024-06619
• Device Sequence Number: 9133221
• Product Code: ESW
• UDI-Device Identifier: 00191506006655
• UDI-Public: 00191506006655
• 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
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/28/2026
• Device Model Number: M00517780
• Device Catalogue Number: M00517780
• Device Lot Number: 0033719985
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 01/16/2025
• Date Device Manufactured: 03/28/2024
• 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
• Patient Sex: Male
• Patient Race: White