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

Model Number	M00513730
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable events of stent migration and stent cover migration.Imdrf impact code f2301 captures the reportable event of the stent was removed using forceps.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered distal release stent was to be implanted in the esophagus to treat an approximately 5 cm exogenous benign esophageal tumor during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the ultraflex esophageal stent was deployed.However, the position of the stent cover was changed.The stent and stent cover had migrated, which prompted the physician to remove the stent using forceps.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block b5 (describe event or problem) and h6 (device codes) were updated following a medical review which determined that the device was inappropriately used to treat a benign tumor.Block h6: imdrf device code a010402 captures the reportable events of stent migration.Imdrf device code a04 captures the reportable events of stent cover damaged/defective.Imdrf impact code f2301 captures the reportable event of the stent was removed using forceps.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered distal release stent was to be implanted in the esophagus to treat an approximately 5 cm exogenous benign esophageal tumor during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the ultraflex esophageal stent was deployed.However, the position of the stent cover was changed.The stent and stent cover had migrated, which prompted the physician to remove the stent using forceps.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the stent was used to treat a benign tumor.The ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for placement to treat a benign tumor.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal covered distal release stent was to be implanted in the esophagus to treat an approximately 5 cm exogenous benign esophageal tumor during an esophageal stent placement procedure performed on (b)(6) 2025.During the procedure, the ultraflex esophageal stent was deployed.However, the position of the stent cover was changed.The stent and stent cover had migrated, which prompted the physician to remove the stent using forceps.Another of the same device was used to complete the procedure.There were no patient complications reported as a result of this event and the patient condition after the procedure was reported to be stable.Note: it was reported that the stent was used to treat a benign tumor.The ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula.The device is not indicated for placement to treat a benign tumor.
Additional Manufacturer Narrative
Block h6: imdrf device code a010402 captures the reportable events of stent migration.Imdrf device code a04 captures the reportable events of stent cover damaged/defective.Imdrf impact code f2301 captures the reportable event of the stent was removed using forceps.Block h11: an ultraflex esophageal stent was received for analysis.Visual examination of the returned device found the stent fully expanded and deployed.No other problems were noted with the stent and delivery system.Product analysis was unable to confirm the reported events of stent migration and stent cover damaged/defective as the stent was returned fully expanded and deployed.The reported event of stent migration is noted within the instructions for use (ifu) as a possible adverse event associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.A labeling review was performed and, from the information available, this device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the stent was used to treat a benign tumor.The ifu states, "the ultraflex esophageal ng stent system is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only.The ultraflex esophageal ng covered stent system is also indicated for occlusion of concurrent esophageal fistula." the device is not indicated for placement to treat a benign tumor.Additionally, stent migration is noted within the ifu as possible adverse event associated with the use of the device.

• Brand Name: ULTRAFLEX? ESOPHAGEAL NG
• 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: 23457319
• Report Number: 3005099803-2025-05709
• Device Sequence Number: 18371948
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260101(10)33120294
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K130004
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2026

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 Expiration Date: 01/01/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033120294
• 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: 10/10/2025
• Supplement Date Received by Manufacturer: 12/04/2025; 12/31/2025
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/28/2025; 01/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/02/2024
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 68 KG