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

Model Number	M00513740
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a ultraflex esophageal stent was to be implanted in the esophagus to treat a 7mm by 90mm malignant esophageal obstruction during an esophageal stent implantation procedure performed on march (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the shaft of the stent system entered the narrow stenosed site.They attempted to pull the suture to deploy the stent; however, the stent did not deploy.When they continued pulling the suture, they found that the deployment suture was knotted resulting in stent deployment failure.The stent was not fully covered by the deployment suture when it was removed from the patient.The procedure was completed with another of the same device.There was no patient complications reported as a result of this event and the patient's condition was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an axios stent and electrocautery enhanced delivery system was received for analysis.Visual examination of the returned device found the stent partially deployed.The suture was not found knotted, therefore the functional testing related to the deployment of the stent, by pulling the finger ring was performed.The stent deployed without problems; no resistance was felt.Product analysis did not confirm the reported event of stent deployment suture knotted as during product analysis; the suture was not found knotted.The reported event of stent partially deployed was confirmed as the stent was returned partially deployed.The investigation concluded that the reported events were most likely procedural factors as lesion characteristics, handling of the device and the technique used by the physician (force applied).Therefore, a review and analysis of all available information indicated the most probable cause of the reported events is adverse event related to procedure.
Additional Manufacturer Narrative
B5 and h6 (device codes) have been corrected.H6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that a ultraflex esophageal stent was to be implanted in the esophagus to treat a 7mm by 90mm malignant esophageal obstruction during an esophageal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the shaft of the stent system entered the narrow stenosed site.They attempted to pull the suture to deploy the stent; however, the stent did not deploy.When they continued pulling the suture, they found that the deployment suture was knotted resulting in stent deployment failure.The stent was not fully covered by the deployment suture when it was removed from the patient.The procedure was completed with another of the same device.There was no patient complications reported as a result of this event and the patient's condition was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation that a ultraflex esophageal stent was to be implanted in the esophagus to treat a 77mm by 90mm malignant esophageal obstruction caused by cancer during an esophageal stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the shaft of the stent system entered the narrow stenosed site.They attempted to pull the wire to deploy the stent; however, the stent failed to deploy.When they continued pulling the wire, they found that the deployment suture was knotted resulting in stent deployment failure.The stent was not fully covered by the deployment suture when it was removed from the patient.The procedure was completed with another of the same device.There was no patient complications reported as a result of this event and the patient's condition was reported to be stable.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21872476
• Report Number: 3005099803-2025-01727
• Device Sequence Number: 7719092
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167(17)260319(10)33659663
• 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): 06/17/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/19/2026
• Device Model Number: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0033659663
• 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: 03/26/2025
• Supplement Date Received by Manufacturer: 04/21/2025; 05/21/2025
• Initial Report FDA Received Date: 04/21/2025
• Supplement Report FDA Received Date: 04/21/2025; 06/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2024
• 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: Male
• Patient Weight: 75 KG