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

Model Number	M00516720
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of stent cover damaged-defective.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be used in the esophagus to treat esophageal stenosis during an endoscopic esophageal stent placement procedure performed on (b)(6) 2025.Prior to procedure, it was reported that the tip of the stent cover was damaged.The procedure was completed with another stent of the same model.There were no patient complications reported as a result this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of stent cover damaged-defective.Imdrf device code a15 captures the reportable event of stent partially deployed based on investigation.Block h11: a wallflex esophageal fully covered stent was received for analysis.The stent was returned partially deployed and the stent cover was damaged.No other damage was noted to the device.Product analysis confirmed the reported event of stent failure to deploy.The investigation concluded that the damages found in the device were most likely due to procedure factors such as lesion characteristics, handling of the device, and the technique used by the physician that could have resulted to the stent being unable to deploy during the procedure.Based on all available information, the investigation selected that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be used in the esophagus to treat esophageal stenosis during an endoscopic esophageal stent placement procedure performed on (b)(6) 2025.Prior to procedure, it was reported that the tip of the stent cover was damaged.The procedure was completed with another stent of the same model.There were no patient complications reported as a result this event.

• 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: 23145799
• Report Number: 3005099803-2025-04798
• Device Sequence Number: 9284656
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: (01)08714729778059(17)250920(10)33450513
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 11/25/2025

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: 09/20/2025
• Device Model Number: M00516720
• Device Catalogue Number: M00516720
• Device Lot Number: 0033450513
• 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: 09/02/2025
• Supplement Date Received by Manufacturer: 11/02/2025
• Initial Report FDA Received Date: 09/25/2025
• Supplement Report FDA Received Date: 11/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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 Age: 68 YR
• Patient Sex: Male
• Patient Weight: 83 KG