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

Model Number	M00516730
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable event of additional device required.Block h11: age at time of event: 18 years or older.
Event or Problem Description
It was reported to boston scientific corporation that the wallflex esophageal stents was to be implanted to malignant stricture during a gastroscopy with esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the stent was placed and was deployed distally beyond the stricture.The stent was difficult to remove as the stricture was too tight.The procedure completed using an alternate device.There was no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that the wallflex esophageal stents was to be implanted to a malignant stricture during a gastroscopy with esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the stent was placed and was deployed distally beyond the stricture.The stent was difficult to remove as the stricture was too tight.The procedure completed using an alternate device.There was no patient complications reported as a result of this event.Additional information received on may 26, 2025: the second stent was placed in the most effective position; just before the stricture and inside the first stent.The physician was confident with its placement.
Additional Manufacturer Narrative
Block b5 has been updated based on the additional information received on may 26, 2025.Block a2: age at time of event: 18 years or older.Block h6: imdrf device code a1502 captures the reportable event of stent positioning problem.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable event of additional device required.

• 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: 22091398
• Report Number: 3005099803-2025-02358
• Device Sequence Number: 7866167
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: (01)08714729778066(17)260206(10)34585494
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K233939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2025

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: 02/06/2026
• Device Model Number: M00516730
• Device Catalogue Number: M00516730
• Device Lot Number: 0034585494
• 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: 05/07/2025
• Supplement Date Received by Manufacturer: 05/26/2025
• Initial Report FDA Received Date: 05/27/2025
• Supplement Report FDA Received Date: 06/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/07/2024
• 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 Sex: Unknown