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

Model Number	M00516740
Medical Device Problem Codes	Failure to Advance (2524); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the esophagus to treat a malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the delivery system encountered difficulty in advancing through the stricture.The device was removed; however, the tip of the catheter broke.The tip was on the wire, and it was removed with the help of the wire.The delivery system was removed, and another wallflex esophageal stent was used to complete the procedure.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 fully covered stent was implanted in the esophagus to treat a malignant esophageal stricture during an esophageal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, the delivery system encountered difficulty in advancing through the stricture.The device was removed; however, the tip of the catheter broke.The tip was on the wire, and it was removed with the help of the wire.The delivery system was removed, and another wallflex esophageal stent was used to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of tip detachment of device or device component.Block h11: a wallflex esophageal fully covered stent was returned for analysis.The stent was returned fully covered and undeployed.Visual examination of the returned delivery system found the tip was detached as it was not returned, and the outer sheath was kinked.No other damages were noted to the stent and the delivery system.The reported event of tip detached was confirmed as the device tip did not return.Product analysis did not confirm the reported event of delivery system difficult to cross lesion as this event occurred during the procedure.The investigation analysis concluded that this can be attributed to the manufacturing process.Additionally, visual inspection found kinked on the outer sheath, likely due to procedural factors such as excess of force or the manner as the device was handled and manipulated, limited the performance of the device and contributed to the observed problems.Taking all available information into consideration, the overall root cause of the reported event is manufacturing deficiency.In april 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 01 november 2023 through 25 january 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 01 november 2023 through 25 january 2024.Boston scientific also initiated a voluntary medical device removal of impacted batches (i.E., products manufactured between 01 november 2023 and 25 january 2024) of the wallflex esophageal stent system in august 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.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19765006
• Report Number: 3005099803-2024-03444
• Device Sequence Number: 20960792
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: 08714729778073
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Recall,Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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: 06/28/2025
• Device Model Number: M00516740
• Device Catalogue Number: 1674
• Device Lot Number: 0032927196
• 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: 06/27/2024
• Supplement Date Received by Manufacturer: 09/10/2024
• Initial Report FDA Received Date: 07/17/2024
• Supplement Report FDA Received Date: 09/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/27/2023
• 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: Female