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

Model Number	M00516720
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled/rescheduled.Post sedation/sedation unknown.Block e1: initial reporter address: (b)(6) hospital; reported here as the address exceeded character limit for the designated field.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was intended to be implanted in the esophagus to treat a 10 cm esophageal stricture caused by cancer during an esophageal stenting procedure performed on (b)(6) 2026.The anatomy of the patient was torturous and was dilated prior to stent placement.During procedure, the physician advanced the wire across the stricture and performed a controlled radial expansion (cre) 10 mm to 12 mm to dilate the stricture so stent could easily cross.Post dilation, the wall flex esophageal fully covered stent was loaded on the wire and placed across the stricture.The stricture was tight which caused the stent not to open.The physician tried multiple attempts but still was not able to deploy the stent.When the stent was removed from the patient, the stent remained fully covered by the outer sheath.The procedure was not completed due to this event.There is no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 captures the reportable event of cancelled/rescheduled - post sedation/sedation unknown.Block e1: initial reporter address: amrita hospital project faridabad mata amritanandamayi marg, sector 88; reported here as the address exceeded character limit for the designated field.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent failure to deploy.The device has not been returned for product evaluation; therefore, a technical analysis could not be performed.Based on the information available and without proper evaluation of the device, it is unknown if the reported events were due to the physician's technique during the procedure, or whether it was related to a device malfunction.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: the complaint device was not returned for evaluation; therefore, a technical analysis could not be performed.Risk review: a risk review was completed and confirmed that the events of stent failure to deploy and cancelled/rescheduled - post sedation/sedation unknown 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 unable to exclude device problem.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was intended to be implanted in the esophagus to treat a 10 cm esophageal stricture caused by cancer during an esophageal stenting procedure performed on (b)(6) 2026.The anatomy of the patient was torturous and was dilated prior to stent placement.During procedure, the physician advanced the wire across the stricture and performed a controlled radial expansion (cre) 10mm to 12mm to dilate the stricture so stent could easily cross.Post dilation, the wall flex esophageal fully covered stent was loaded on the wire and placed across the stricture.The stricture was tight which caused the stent not to open.The physician tried multiple attempts but still was not able to deploy the stent.When the stent was removed from the patient, the stent remained fully covered by the outer sheath.The procedure was not completed due to this event.There is no patient complications reported as a result of the procedure.

• 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: 24519565
• Report Number: 3005099803-2026-00802
• Device Sequence Number: 9691974
• Product Code: ESW
• UDI-Device Identifier: 08714729778059
• UDI-Public: (01)08714729778059(17)261010(10)36271403
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/10/2026

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: M00516720
• Device Catalogue Number: M00516720
• Device Lot Number: 0036271403
• 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: 02/05/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 03/05/2026
• Supplement Report FDA Received Date: 04/10/2026
• Date Device Manufactured: 04/10/2025
• 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
• Patient Race: American Indian Or Alaskan Native