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	12/11/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.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 used to treat a malignant esophageal stenosis during an esophageal metal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not 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 was no patient complications were reported due to this event.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was used to treat a malignant esophageal stenosis during an esophageal metal stent placement procedure performed on (b)(6) 2024.The patient's anatomy was not tortuous and was not 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 was no patient complications were reported due to this event.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: an ultraflex esophageal stent with the delivery system was received for analysis; the stent was fully expanded and deployed.The shaft was returned kinked.No other issues were found with the returned device product analysis could not confirm the reported event of stent partially deployed as the stent was returned fully expanded and deployed.The investigation concluded that the additional observed problem of the shaft kinked was likely due to factors encountered during the procedure.Lesion characteristics, handling of the device, and the technique used by the physician (force applied) may have limited the device's performance and contributed to the observed problem.Taking all available information into consideration, the overall root cause of the reported event is "no problem detected.".

• 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: 21106370
• Report Number: 3005099803-2024-06768
• Device Sequence Number: 12957513
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: 08714729716167
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 03/04/2025

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: 03/25/2026
• Device Model Number: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0033696554
• 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: 12/11/2024
• Supplement Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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 Sex: Unknown