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

Model Number	M00513730
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2025
Type of Reportable Event	Malfunction
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 an ultraflex esophageal distal release covered stent was to be implanted to treat a 3cm malignant complete obstruction of the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the stent could not be deployed.The stent was removed from the patient partially deployed and the procedure was completed using another ultraflex esophageal stent.There was no patient complications reported as a result of this event and the patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block d4 lot number has been updated with the additional information received on may 20, 2025.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 and the stent deployment suture was not returned as it was detached.Therefore, a functional test could not be performed.No other damages were found with the stent or the delivery system.Product analysis confirmed the reported event of stent partially deployed as the stent was returned in this condition.The investigation concluded that the reported event and additional observed event of deployment suture break were most likely due to procedural factors such 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 events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted to treat a 3cm malignant complete obstruction of the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was removed from the patient partially deployed and the procedure was completed using another ultraflex esophageal stent.There was no patient complications reported as a result of this event and the patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block d4 lot number has been updated with the additional information received on may 20, 2025.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 and the stent deployment suture was not returned as it was detached.Therefore, a functional test could not be performed.No other damages were found with the stent or the delivery system.Product analysis confirmed the reported event of stent partially deployed as the stent was returned in this condition.The investigation concluded that the reported event and additional observed event of deployment suture break were most likely due to procedural factors such 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 events is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted to treat a 3cm malignant complete obstruction of the lower esophagus during an esophageal stent placement procedure performed on (b)(6) 2025.The patient's anatomy was tortuous prior to stent placement.During the procedure, the stent could not be deployed.The stent was removed from the patient partially deployed and the procedure was completed using another ultraflex esophageal stent.There was no patient complications reported as a result of this event and the patient's condition following the procedure 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: 21807982
• Report Number: 3005099803-2025-01484
• Device Sequence Number: 8799188
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260126(10)33300923
• 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): 07/08/2025

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: 01/16/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033224413
• 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: 03/18/2025
• Supplement Date Received by Manufacturer: 05/20/2025; 06/14/2025
• Initial Report FDA Received Date: 04/09/2025
• Supplement Report FDA Received Date: 06/12/2025; 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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: 60 YR
• Patient Sex: Male
• Patient Weight: 60 KG