MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION AGILE? ESOPHAGEAL; 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	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block g2: report source (other): e7118 boston scientific post market surveillance data collection.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Block h11: the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Taking all available information into consideration, the investigation concluded that the reported event of stent migration is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, stent migration is noted within the ifu as a possible adverse event associated with the use of the device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted to treat a malignant stricture during a procedure performed on (b)(6) 2024.It was reported that on an unknown date, the stent had migrated.Note: no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted to treat a malignant stricture during a procedure performed on (b)(6) 2024.It was reported that on an unknown date, the stent had migrated.Note: no further information has been obtained despite good faith efforts.***additional information received on march 28, 2025*** it was reported that the agile esophageal stent was to be implanted to treat a 5mm polypoid obstructing mass in the esophagus during an upper gi endoscopy procedure performed on (b)(6) 2024.
Additional Manufacturer Narrative
Block a2, a3a, a3b, b3, b5, e1, have been updated with the additional information received on march 28, 2025.Block a4: patient's weight :70.8 block b3: approximated based on the date the manufacturer became aware of the event.Block g2: report source (other): e7118 boston scientific post market surveillance data collection.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Block h11: the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Taking all available information into consideration, the investigation concluded that the reported event of stent migration is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, stent migration is noted within the ifu as a possible adverse event associated with the use of the device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted to treat a malignant stricture during a procedure performed on november 19, 2024.It was reported that on an unknown date, the stent had migrated.Note: no further information has been obtained despite good faith efforts.Additional information received on march 28, 2025.It was reported that the agile esophageal stent was to be implanted to treat a 5mm polypoid obstructing mass in the esophagus during an upper gi endoscopy procedure performed on (b)(6) 2024.Additional information received on april 4, 2025, and april 16, 2025.It was reported that the indication was not resolved at the time of the migration.Additionally, on (b)(6) 2025, the migrated stent was removed with a raptor grasping device.
Additional Manufacturer Narrative
Blocks b1, b2, b5, g2, h1 and h6 (impact codes) have been corrected with the additional information received on april 4, 2025, and april 16, 2025.Block a4: patient's weight :70.8.Block b3: approximated based on the date the manufacturer became aware of the event.Block g2: report source (other): e7118 boston scientific post market surveillance data collection block h6: imdrf device code a010402 captures the reportable event of stent migration block h11: the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Taking all available information into consideration, the investigation concluded that the reported event of stent migration is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, stent migration is noted within the ifu as a possible adverse event associated with the use of the device.
Event or Problem Description
It was reported to boston scientific corporation that an agile esophageal stent was implanted to treat a malignant stricture during a procedure performed on (b)(6) 2024.It was reported that on an unknown date, the stent had migrated.Additional information received on march 28, 2025: it was reported that the agile esophageal stent was to be implanted to treat a 5mm polypoid obstructing mass in the esophagus during an upper gi endoscopy procedure performed on (b)(6) 2024.Additional information received on april 4, 2025, and april 16, 2025: it was reported that the indication was not resolved at the time of the migration.Additionally, on (b)(6) 2025, the migrated stent was removed with a raptor grasping device.
Additional Manufacturer Narrative
Blocks g2 (report source), h6 (impact codes), and h11 have been corrected.Block a4: patient's weight: 70.8 kg.Block b3: approximated based on the date the manufacturer became aware of the event.Block g2: report source (other): e7118 boston scientific post market surveillance data collection block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2202 captures the procedure performed to remove the migrated stent.Block h11: the complaint device was not returned to boston scientific; therefore, product analysis could not be performed.Taking all available information into consideration, the investigation concluded that the reported event of stent migration is a known potential complication associated with the use of the device in the manufacturer's labeling.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.Additionally, stent migration is noted within the ifu as a possible adverse event associated with the use of the device.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21654082
• Report Number: 3005099803-2025-01121
• Device Sequence Number: 15337403
• Product Code: ESW
• UDI-Device Identifier: 00191506006631
• UDI-Public: (01)00191506006631(11)240730(17)260730(10)34534647
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K233837
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/07/2025

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: 07/30/2026
• Device Model Number: M00517760
• Device Catalogue Number: M00517760
• Device Lot Number: 0034534647
• 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: 02/24/2025
• Supplement Date Received by Manufacturer: 03/28/2025; 05/07/2025; 07/18/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/24/2025; 05/08/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/30/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 67 YR
• Patient Sex: Male