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

Model Number	M00514250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to october 01, 2025; as no event date was reported.Block h6: imdrf device code a0406 captures the reportable event of stent break.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure performed to remove the broken stent.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus to treat an unspecified condition during a procedure performed on an unknown date.Reportedly, two weeks after the implant procedure, the stent ruptured inside the patient esophagus.The stent was subsequently explanted.There were no patient complications reported due to this event.
Additional Manufacturer Narrative
Block b3: date of event: date of event was approximated to october 01, 2025; as no event date was reported.Block h6: imdrf device code a0406 captures the reportable event of stent break.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure performed to remove the broken stent.Block h11: an ultraflex esophageal stent was returned for analysis.A visual examination of the returned device revealed that the handle was not included in the return.Only the stent was received, and its wires were found broken.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent break.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to procedural factors such as lesion characteristics, device handling, and the technique used by the physician, which could have resulted in the damages and wire detachments encountered in the device.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus to treat an unspecified condition during a procedure performed on an unknown date.Reportedly, two weeks after the implant procedure, the stent ruptured inside the patient esophagus.The stent was subsequently explanted.There were no patient complications reported due to this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was implanted in the esophagus to treat an unspecified condition during a procedure performed on an unknown date.Reportedly, two weeks after the implant procedure, the stent ruptured inside the patient esophagus.The stent was subsequently explanted.There were no patient complications reported due to this event.Additional information received on november 24, 2025.It was reported that the correct indication for the procedure was an esophageal stricture.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on november 24, 2025.Block b3: date of event: date of event was approximated to october 01, 2025; as no event date was reported.Block h6: imdrf device code a0406 captures the reportable event of stent break.Imdrf impact code f2202 captures the reportable event of the endoscopic procedure performed to remove the broken stent.Block h11: an ultraflex esophageal stent was returned for analysis.A visual examination of the returned device revealed that the handle was not included in the return.Only the stent was received, and its wires were found broken.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported event of stent break.Taking all available information into consideration, the investigation concluded that the reported event and observed damage were likely due to procedural factors such as lesion characteristics, device handling, and the technique used by the physician, which could have resulted in the damages and wire detachments encountered in the device.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu)/product label.

• 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: 23576970
• Report Number: 3005099803-2025-06149
• Device Sequence Number: 9259656
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: (01)08714729716112(17)270513(10)36503511
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/12/2026

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: M00514250
• Device Catalogue Number: M00514250
• Device Lot Number: 0036503511
• 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: 10/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025; 12/18/2025
• Initial Report FDA Received Date: 11/17/2025
• Supplement Report FDA Received Date: 12/11/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2025
• 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