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

Model Number	M00516740
Medical Device Problem Codes	Difficult to Remove (1528); Device-Device Incompatibility (2919); Positioning Problem (3009)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the gastroesophageal junction to treat a malignant distal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure on (b)(6) 2025.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, it was reported that the esophageal stent was successfully deployed.However, the physician drove a gastroscope through the stent causing it to dislodge distally into the stomach.The procedure was prolonged for approximately 1 hour as attempts to retrieve the stent using snares and rat tooth forceps were made.Despite the efforts, the device was not able to be retrieved; the physician is going to schedule a future procedure to remove it eventually.The procedure was completed by implanting another wallflex stent.The patient's condition was stable after the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the gastroesophageal junction to treat a malignant distal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure on (b)(6) 2025.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, it was reported that the esophageal stent was successfully deployed.However, the physician drove a gastroscope through the stent causing it to dislodge distally into the stomach.The procedure was prolonged for approximately 1 hour as attempts to retrieve the stent using snares and rat tooth forceps were made.Despite the efforts, the device was not able to be retrieved; the physician is going to schedule a future procedure to remove it eventually.The procedure was completed by implanting another wallflex stent.The patient's condition was stable after the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6 (device codes) has been updated.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the gastroesophageal junction to treat a malignant distal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure on (b)(6) 2025.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, it was reported that the esophageal stent was successfully deployed.However, the physician drove a gastroscope through the stent causing it to dislodge distally into the stomach.The procedure was prolonged for approximately 1 hour as attempts to retrieve the stent using snares and rat tooth forceps were made.Despite the efforts, the device was not able to be retrieved; the physician is going to schedule a future procedure to remove it eventually.The procedure was completed by implanting another wallflex stent.The patient's condition was stable after the procedure.There were no patient complications reported as a result of this event.Additional information received on january 28, 2026: it was later confirmed that the stent was removed from the patient's stomach on an unknown date.
Additional Manufacturer Narrative
Block b5 (describe event or problem) and block h6 (patient codes) have been updated based on the additional information received on january 28, 2026.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf impact code f2301 captures the reportable of additional device required (snares and rat tooth forceps).Imdrf impact code f2301 captures the reportable of the endoscopic procedure scheduled to retrieve the stent.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted in the gastroesophageal junction to treat a malignant distal stricture during an esophagogastroduodenoscopy (egd) with stent placement procedure on (b)(6) 2025.The patient's anatomy was tight and was not dilated prior to stent placement.During the procedure, it was reported that the esophageal stent was successfully deployed.However, the physician drove a gastroscope through the stent causing it to dislodge distally into the stomach.The procedure was prolonged for approximately 1 hour as attempts to retrieve the stent using snares and rat tooth forceps were made.Despite the efforts, the device was not able to be retrieved; the physician is going to schedule a future procedure to remove it eventually.The procedure was completed by implanting another wallflex stent.The patient's condition was stable after the procedure.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 a1502 captures the reportable event of stent positioning issue.Imdrf device code a150207 captures the reportable event of stent difficult to remove.Imdrf patient code e2008 captures the reportable event of unretrieved device fragments.Imdrf impact code f2301 captures the reportable 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: 23607546
• Report Number: 3005099803-2025-06193
• Device Sequence Number: 9848911
• Product Code: ESW
• UDI-Device Identifier: 08714729778073
• UDI-Public: (01)08714729778073(17)270307(10)37379789
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091510
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup,Followup
• Report Date (Section B): 02/23/2026

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: M00516740
• Device Catalogue Number: M00516740
• Device Lot Number: 0037379789
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 10/24/2025; 12/29/2025; 01/28/2026
• Initial Report FDA Received Date: 11/20/2025
• Supplement Report FDA Received Date: 11/21/2025; 01/26/2026; 02/23/2026
• Date Device Manufactured: 09/05/2025
• 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 Age: 50 YR
• Patient Sex: Female