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

Model Number	M00513730
Medical Device Problem Codes	Unraveled Material (1664); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
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 in the esophagus to treat a 5cm malignant stenosis during a stent implantation procedure performed on march 26, 2025.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, the posterior segment of 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.The patient's condition at the conclusion of 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 h11: an ultraflex esophageal stents was received for analysis; the delivery system was not returned for analysis.Visual inspection revealed that the stent returned was fully expanded, deployed and unraveled.No other damages were noted to the stent.Product analysis could not confirm the reported event of stent partially deployed due to the condition the stent was returned (unraveled).The investigation concluded that the additional observed stent damage was most likely due to procedural factors as lesion characteristics, handling of the device, and the technique used by the physician (force applied).There is no objective evidence to confirm the reported event.Therefore, based on the available information, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal distal release covered stent was to be implanted in the esophagus to treat a 5cm malignant stentosis during a stent implantation procedure performed on (b)(6) 2025.The patient's anatomy was tortuous.During the procedure, the stent was attempted to be deployed; however, the posterior segment of 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.The patient's condition at the conclusion of 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: 21850912
• Report Number: 3005099803-2025-01689
• Device Sequence Number: 15605361
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)260411(10)33803798
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2025

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: 04/11/2026
• Device Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0033803798
• 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: 05/21/2025
• Initial Report FDA Received Date: 04/16/2025
• Supplement Report FDA Received Date: 06/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/11/2024
• 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: 55 YR
• Patient Sex: Male
• Patient Weight: 71 KG