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

Model Number	M00516700
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	09/11/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat esophageal cancer with 7cm lesion during a procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, stent displacement was observed.It was noted that the stent was implanted in the correct position; however, the patient reported discomfort, and the stent was found to be shifted.Subsequently, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no further patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required to remove the migrated stent.
Additional Manufacturer Narrative
Block b5, block d6a, block d6b, and block h6 (impact codes) have been updated.Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required to remove the migrated stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat esophageal cancer with 7cm lesion during a procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, stent displacement was observed.It was noted that the stent was implanted in the correct position; however, the patient reported discomfort, and the stent was found to be shifted.Subsequently, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no further patient complications reported as a result of this event.Additional information received on october 8, 2025 and october 20, 2025: it was later confirmed that the stent was implanted on (b)(6) 2025.On (b)(6) 2025, the patient experienced discomfort, and the migrated stent was confirmed via imaging.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable event of stent migration.Imdrf impact code f2301 captures the reportable event of additional device required to remove the migrated stent.Block h11: a wallflex esophageal stent was received for analysis.Visual inspection showed that the stent was in good condition.The stent was received fully expanded and deployed.Also, the clear outer sheath was found kinked.No other problems were noted with the stent.Product analysis could not confirm the reported event of stent migration.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, stent migration is known and documented in the labeling and all reasonable steps have been taken (including both short or long term known complications or adverse reactions).Furthermore, the investigation found that the clear outer sheath was kinked.This could be due to procedural factors such as excess force or the manner the device was handled and manipulated, which was classified as adverse event related to procedure.Based on all available information, the investigation selected that the most probable root cause is known inherent risk of device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat esophageal cancer with 7cm lesion during a procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, stent displacement was observed.It was noted that the stent was implanted in the correct position; however, the patient reported discomfort, and the stent was found to be shifted.Subsequently, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no further patient complications reported as a result of this event.Additional information received on october 8, 2025 and october 20, 2025: it was later confirmed that the stent was implanted on (b)(6) 2025.On (b)(6) 2025, the patient experienced discomfort, and the migrated stent was confirmed via imaging.

• Brand Name: WALLFLEX? 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23215969
• Report Number: 3005099803-2025-05080
• Device Sequence Number: 9075785
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: (01)08714729778035(17)250926(10)33497105
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2025

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: 09/26/2025
• Device Model Number: M00516700
• Device Catalogue Number: M00516700
• Device Lot Number: 0033497105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 11/26/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 10/30/2025; 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2024
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG