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

Model Number	M00516930
Medical Device Problem Codes	Failure to Advance (2524); 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	03/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was attempted to be implanted in the esophagus to treat a 6 cm lesion located 38 cm from the incisors during an esophageal stenting procedure performed on (b)(6) 2026.The patient's anatomy was dilated following the placement attempt.During the procedure, it was observed that the end of the delivery system was bent.The physician was unable to advance the device through the lesion and subsequently withdrew the delivery system to perform dilation.However, this attempt was also unsuccessful.The procedure was ultimately completed using an alternate method.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a04 captures the reportable event of tip damaged/defective.Block b5 has been updated with the additional information that was received on march 24, 2026, and april 08, 2026.Block e1 initial reporter phone has been updated with the additional information that was received on march 24, 2026.Block a3a and a3b patient sex and gender have been updated with the additional information that was received on march 24, 2026.Block h11: investigation summary: based on the available information, boston scientific confirmed the reported events of tip damaged/defective and delivery system difficult to cross.The investigation concluded that the observed damages on the device were most likely caused by procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician (force applied).Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: a wallflex esophageal stent and its delivery system were returned for analysis.Visual examination of the returned device identified the sheath kinked and the tip bent.Labeling review: a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.Risk review: a risk review was completed and confirmed that the event of tip damaged/defective were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was attempted to be implanted in the esophagus to treat a 6 cm lesion located 38 cm from the incisors during an esophageal stenting procedure performed on (b)(6) 2026.The patient's anatomy was dilated following the placement attempt.During the procedure, it was observed that the end of the delivery system was bent.The physician was unable to advance the device through the lesion and subsequently withdrew the delivery system to perform dilation.However, this attempt was also unsuccessful.The procedure was ultimately completed using an alternate method.No patient complications were reported as a result of this event.Additional information was received on march 24, 2026, and april 08, 2026.The type of procedure performed is esophagogastroduodenoscopy.The anatomy of the patient was torturous.The procedure was completed by dilating the anatomy of the patient and using the original device.

• 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: 24738579
• Report Number: 3005099803-2026-01153
• Device Sequence Number: 15774665
• Product Code: ESW
• UDI-Device Identifier: 08714729765271
• UDI-Public: (01)08714729765271(17)280217(10)38618910
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 04/21/2026

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 Model Number: M00516930
• Device Catalogue Number: M00516930
• Device Lot Number: 0038618910
• 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: 03/09/2026
• Supplement Date Received by Manufacturer: 03/24/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 04/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/17/2026
• 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