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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted for the treatment of esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was removed from the patient partially deployed and a different device was used to complete the procedure.There were no patient complications as a result of this event.
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 for the treatment of esophageal cancer during an esophageal stenting procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was removed from the patient partially deployed and a different device was used to complete the procedure.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal distal release covered stent and delivery system were returned for analysis.Visual examination of the returned device revealed that the stent was partially deployed.A functional examination was performed by pulling the finger ring, and although the stent was able to be deployed, high resistance was noted along with a problem in stent expansion.No other problems were noted to the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.Taking all available information into consideration, the investigation concluded that the reported events and the observed damages were likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and/or the technique used by the physician, limited the performance of the device and may have contributed to the reported events and the observed damages.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.

• 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: 18519662
• Report Number: 3005099803-2023-07163
• Device Sequence Number: 17830281
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2025

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: 10/05/2024
• Device Model Number: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0030291185
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 10/07/2025
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 11/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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: 64 YR
• Patient Sex: Male