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

Model Number	M00516700
Medical Device Problem Codes	Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Reported here as these exceeded the maximum character limit of the designated fields.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged/defective.Imdrf impact code f2301 captures the additional tool required to remove the complaint stent from the patient.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted to treat a tumor in the esophagus during an esophageal stent placement procedure performed on july 16, 2025.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent cover broke post-deployment, causing the tissue to squeeze the mesh into the stent while the stent cover remained attached.Subsequently, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted to treat a malignant tumor in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent cover broke post-deployment, causing the tissue to squeeze the mesh into the stent while the stent cover remained attached.Subsequently, the stent was removed using snares.The procedure was completed with another stent of the same model.There were no patient complications reported as a result of this event.Additional information on september 27, 2025: it was later confirmed that the tumor is malignant.
Additional Manufacturer Narrative
Block b5 and block g1 (manufacturer contact person) have been updated.Block e1: initial reporter facility name: (b)(6).Reported here as these exceeded the maximum character limit of the designated fields.Block h6: imdrf device code a04 captures the reportable event of stent cover damaged/defective.Imdrf impact code f2301 captures the additional tool required to remove the complaint stent from the patient.Block h11: a wallflex esophageal delivery system was returned for analysis, the stent was not returned.Visual inspection found both the outer sheath and the inner sheath kinked.No other damages were noted.Product analysis could not confirm the reported event of stent cover damaged/defective as the stent was not returned for analysis.The investigation concluded that the additional observed damages on the delivery system were most likely caused by procedural factors such as lesion characteristics, handling of the device and the technique used by the physician (force applied).Based on the information available and without proper evaluation of the stent, cause not established is selected as the most probable root cause.

• 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: 22745370
• Report Number: 3005099803-2025-03850
• Device Sequence Number: 12858464
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: (01)08714729778035(17)260311(10)34804846
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K233939
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2025

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: 03/11/2026
• Device Model Number: M00516700
• Device Catalogue Number: M00516700
• Device Lot Number: 0034804846
• 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: 07/16/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 10/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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: 83 YR
• Patient Sex: Male
• Patient Weight: 69 KG