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

Model Number	M00516900
Medical Device Problem Codes	Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be used to treat an impassable esophageal cancer during a procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure.The device could not pass through the tumour.The device was removed was then removed from the patient.Upon inspection, it was noted that the tip of the delivery system was slightly separated from the sheath.No patient complications were reported as a result of this event.
Additional Manufacturer Narrative
Block g4: premarket/510(k) k073266, k233939 - reported here as it exceeded the number of maximum character limit for the designated field.Block h6: imdrf device code a15 captures the reportable event of partially deployed esophageal stent.
Additional Manufacturer Narrative
Block b5 has been corrected.Block g4: premarket/510(k) k073266, k233939 - reported here as it exceeded the number of maximum character limit for the designated field.Block h6: imdrf device code a15 captures the reportable event of partially deployed esophageal stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be used to treat an impassable esophageal cancer during a procedure performed on (b)(6) 2024.The patient's anatomy was not dilated prior to stent placement.During the procedure, the device could not pass through the tumor.The device was then removed from the patient.Upon inspection, it was noted that the tip of the delivery system was slightly separated from the sheath.No patient complications were reported as a result of 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 21172058
• Report Number: 3005099803-2025-00067
• Device Sequence Number: 11913097
• Product Code: ESW
• UDI-Device Identifier: 08714729765240
• UDI-Public: 08714729765240
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K073266
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/24/2025

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 Model Number: M00516900
• Device Catalogue Number: M00516900
• Device Lot Number: 0035106337
• 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: 12/19/2024
• Supplement Date Received by Manufacturer: 01/23/2025
• Initial Report FDA Received Date: 01/16/2025
• Supplement Report FDA Received Date: 01/24/2025
• Date Device Manufactured: 10/21/2024
• 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
• Patient Sex: Unknown