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

Model Number	M00516700
Medical Device Problem Code	Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf device code 2423 captures the reportable event of stent obstruction.Imdrf impact code f2202 captures the reportable event of endoscopic procedure for stent removal.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was to be implanted to treat an malignancy in the esophagus during an esophagogastroduodenoscopy (egd) procedure.The patient, who had a stent placed two weeks ago for malignant obstruction, underwent follow-up endoscopy.During the procedure, the physician identified early tissue ingrowth at the stent site, which was concerning given the short time since placement.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Blocks b5 has been corrected and updated with the additional information received on august 6, 2025.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block d6a: (implant date) it was reported that the stent was placed two weeks prior to the stent removal procedure on (b)(6) 2025.Therefore, (b)(6) 2025 was documented as the implant date.Block h6: imdrf device code 2423 captures the reportable event of stent obstruction.Imdrf impact codes f2202 and f2301captures the reportable event of endoscopic procedure for stent removal and the use of rescue forceps.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant esophageal obstruction during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.On (b)(6) 2025, two weeks post stent placement, the patient underwent a routine follow-up endoscopy.During the procedure, the physician identified early tissue ingrowth at the stent site, which was concerning given the short time since placement.There were no patient complications reported as a result of this event.Additional information received on august 6, 2025.It was reported that the stent was removed from the patient using rescue forceps.Furthermore, no additional stent was placed, and the procedure was completed.
Additional Manufacturer Narrative
Blocks b5 has been corrected and updated with the additional information received on august 6, 2025.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block d6a: (implant date) it was reported that the stent was placed two weeks prior to the stent removal procedure on (b)(6) 2025.Therefore, (b)(6) 2025 was documented as the implant date.Block h6: imdrf device code 2423 captures the reportable event of stent obstruction.Imdrf impact codes f2202 and f2301 captures the reportable event of endoscopic procedure for stent removal and the use of rescue forceps.Block h11: a flexima biliary stent was returned for analysis; delivery system was not return.Upon visual examination of the returned stent, it was observed that tissue ingrowth was present within the stent lumen.The delivery system was not returned and therefore could not be evaluated.Microscopic examination was performed to further assess the condition of the stent.The analysis confirmed the presence of biological tissue embedded within the stent structure, consistent with tissue ingrowth.No other damages were noted to the stent itself.Product analysis confirmed the reported event of stent obstruction within device.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to tissue ingrowth into the stent, which is a known and anticipated complication associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant esophageal obstruction during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.On (b)(6) 2025, two weeks post stent placement, the patient underwent a routine follow-up endoscopy.During the procedure, the physician identified early tissue ingrowth at the stent site, which was concerning given the short time since placement.There were no patient complications reported as a result of this event.Additional information received on august 6, 2025.It was reported that the stent was removed from the patient using rescue forceps.Furthermore, no additional stent was placed, and the procedure was completed.
Additional Manufacturer Narrative
Blocks b5 has been corrected and updated with the additional information received on august 6, 2025.Block h11 has been corrected with the correct product details.Block d4, h4: the complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.Block d6a: (implant date) it was reported that the stent was placed two weeks prior to the stent removal procedure on (b)(6) 2025.Therefore, (b)(6) 2025 was documented as the implant date.Block h6: imdrf device code 2423 captures the reportable event of stent obstruction.Imdrf impact codes f2202 and f2301captures the reportable event of endoscopic procedure for stent removal and the use of rescue forceps.Block h11: a wallflex esophageal stent was returned for analysis; delivery system was not return.Upon visual examination of the returned stent, it was observed that tissue ingrowth was present within the stent lumen.The delivery system was not returned and therefore could not be evaluated.Microscopic examination was performed to further assess the condition of the stent.The analysis confirmed the presence of biological tissue embedded within the stent structure, consistent with tissue ingrowth.No other damages were noted to the stent itself.Product analysis confirmed the reported event of stent obstruction within device.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to tissue ingrowth into the stent, which is a known and anticipated complication associated with the use of this device.Therefore, the most probable root cause is known inherent risk of device.A product labeling review identified that the device was used per the directions for use (dfu) / product label.Additionally, it was confirmed that the following adverse events are anticipated in the ifu: stent obstruction within device.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex esophageal fully covered stent was implanted to treat a malignant esophageal obstruction during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2025.On (b)(6) 2025, two weeks post stent placement, the patient underwent a routine follow-up endoscopy.During the procedure, the physician identified early tissue ingrowth at the stent site, which was concerning given the short time since placement.There were no patient complications reported as a result of this event.Additional information received on august 6, 2025.It was reported that the stent was removed from the patient using rescue forceps.Furthermore, no additional stent was placed, and the procedure was completed.

• 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: 22798609
• Report Number: 3005099803-2025-03971
• Device Sequence Number: 8512339
• Product Code: ESW
• UDI-Device Identifier: 08714729778035
• UDI-Public: (01)08714729778035
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K233939
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted 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,Followup,Followup
• Report Date (Section B): 11/04/2025

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 Model Number: M00516700
• Device Catalogue Number: M00516700
• 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: 07/23/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 09/08/2025; 10/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/02/2025; 10/03/2025; 11/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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