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

Model Number	M00516730
Medical Device Problem Codes	Positioning Problem (3009); Activation Failure (3270)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted in the esophagus to treat an esophageal stricture during a procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous or tight prior to stent placement.During the procedure, the stent was deployed in the esophagus with the distal end positioned in the stomach.Under fluoroscopic observation, it appeared that the distal end of the stent failed to fully expand.The physician attempted to reconstrain the catheter; however, the tip of the delivery system engaged the stent, causing it to migrate proximally.Grasping forceps were then used to reposition the stent, at which point it appeared that the stent had fully expanded.The procedure was completed with the migrated stent remaining in place, and it was reported that the stent will be removed at a later date.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal stent was to be implanted in the esophagus to treat an esophageal stricture during a procedure performed on (b)(6) 2025.The patient's anatomy was not tortuous or tight prior to stent placement.During the procedure, the stent was deployed in the esophagus with the distal end positioned in the stomach.Under fluoroscopic observation, it appeared that the distal end of the stent failed to fully expand.The physician attempted to reconstrain the catheter; however, the tip of the delivery system engaged the stent, causing it to migrate proximally.Grasping forceps were then used to reposition the stent, at which point it appeared that the stent had fully expanded.The procedure was completed with the migrated stent remaining in place, and it was reported that the stent will be removed at a later date.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (patient codes) has been updated.Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23543367
• Report Number: 3005099803-2025-05981
• Device Sequence Number: 13164268
• Product Code: ESW
• UDI-Device Identifier: 08714729778066
• UDI-Public: (01)08714729778066(17)261210(10)36718948
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2026

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 Model Number: M00516730
• Device Catalogue Number: M00516730
• Device Lot Number: 0036718948
• 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: 10/21/2025
• Supplement Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 11/13/2025
• Supplement Report FDA Received Date: 01/26/2026
• Date Device Manufactured: 06/10/2025
• 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