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

Model Number	M00516710
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was used to treat a malignant esophageal stricture during a metal stenting procedure performed on (b)(6) 2024.The patient's anatomy was very tight and was not dilated prior to stent placement.During the procedure, the stent was attempted to be deployed; however, due to the malignancy and it being a tight stricture, the stent was unable to be deployed.The stent was removed from the patient fully covered by the outer sheath.The procedure was not completed.There was no patient complications reported due to this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block g4: premarket/510(k): k091510, k233939; reported here as this exceeded character limit for the designated field.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Additional Manufacturer Narrative
Blocks b5 and g4 have been corrected.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: a wallflex esophageal stent and delivery system were received for analysis.The stent was returned fully covered and undeployed.Functional examination was performed by actuating the delivery system and the stent was deployed without resistance.No issue was noted to the device.Product analysis could not confirm the reported event of stent failure to deploy.Taking all available information into consideration, there is no indication of what the customer reported because the stent was able to be deployed without resistance.Therefore, a review and analysis of all available information indicate the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was used to treat a malignant esophageal stricture during a metal stenting procedure performed on (b)(6) 2024.The patient's anatomy was very tight and was not dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was removed from the patient fully covered by the outer sheath.The procedure was not completed due to malignant stricture.There was no patient complications reported due to 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20885872
• Report Number: 3005099803-2024-06267
• Device Sequence Number: 7921936
• Product Code: ESW
• UDI-Device Identifier: 08714729778042
• UDI-Public: (01)08714729778042(17)241119(10)31464237
• 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): 05/05/2025

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: 11/19/2024
• Device Model Number: M00516710
• Device Catalogue Number: M00516710
• Device Lot Number: 0031464237
• 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: 11/11/2024
• Supplement Date Received by Manufacturer: 04/08/2025
• Initial Report FDA Received Date: 12/09/2024
• Supplement Report FDA Received Date: 05/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2023
• 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