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

Model Number	M00516910
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of a device or device component.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the detached tip.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was implanted to treat an esophageal stenosis in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the conical tip of the stent was detached, resulting in the failure of subsequent implantation and the need for gastroscopy to remove the conical tip.The procedure was not complete the patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on april 23, 2025.Block h6: imdrf device code a0501 captures the reportable event of tip detachment of a device or device component.Imdrf impact code f2301 captures the reportable event of the additional device required to remove the detached tip.Block h11: a wallflex esophageal stent and delivery system were received for analysis.A visual examination of the returned device found the stent fully covered by the outer sheath, with the tip missing as it had detached.A functional examination was performed by actuating the delivery system (sliding the handle back along the stainless-steel tube), and the stent deployed without issues; no resistance was felt.No other damage was noted to the stent or the delivery system.Product analysis confirmed the reported event of tip detachment of device or device component as the device was returned without the tip.The investigation concluded that this event likely occurred due to factors encountered during the manufacturing process.Therefore, review and analysis of all available information indicated the most probable cause is manufacturing deficiency.In (b)(6) 2024, boston scientific initiated a non-conforming events prevention (ncep) investigation to further analyze an increase in "tip detachment of device or device component" complaints associated with the wallflex esophageal stents product family.The investigation found that the observed increase in complaints included devices manufactured from (b)(6) 2023 through (b)(6) 2024.A comprehensive review of the manufacturing process was conducted as part of the investigation to determine if factors within the manufacturing process (i.E., process changes, maintenance routines, calibration activity, materials, personnel, environment, and manufacturing work instructions) could have contributed to overall tip adhesion performance.Although a definitive root cause was not identified, overall manufacturing variation was reduced by modifying maintenance routines associated with process inputs (pad change in tip bond fixture), implementing a material change (glue), and reinforcing training/review of manufacturing work instructions.As a result of this investigation, boston scientific placed a ship hold on all impacted wallflex esophageal stent system products manufactured from (b)(6) 2023 through (b)(6) 2024.Boston scientific also initiated a voluntary medical device removal of impacted batches (i.E., products manufactured between (b)(6) 2023 and (b)(6) 2024) of the wallflex esophageal stent system in (b)(6) 2024 (boston scientific ref.(b)(4)).A corrective and preventative action (capa) investigation has been opened to further investigate these events and determine if additional corrective actions are warranted to further enhance/optimize product performance.This investigation is currently in process.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was implanted to treat an esophageal stenosis in the esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the conical tip of the stent was detached, resulting in the failure of subsequent implantation and the need for gastroscopy to remove the conical tip.The procedure was not complete.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on april 23, 2025.It was reported that the procedure was completed on (b)(6) 2025, with a non-boston scientific 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21597184
• Report Number: 3005099803-2025-01030
• Device Sequence Number: 9034675
• Product Code: ESW
• UDI-Device Identifier: 08714729765257
• UDI-Public: (01)08714729765257(17)260520(10)33860947
• 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,Distributor
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2025

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: 05/20/2026
• Device Model Number: M00516910
• Device Catalogue Number: M00516910
• Device Lot Number: 0033860947
• 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: 02/19/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 55 KG