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	12/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6); reported here as the address exceeded character limit for the designated field.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 stent was to be implanted in the esophagus to treat an 8cm stenosis caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was removed from the patient partially covered with the stent-deployment suture.The procedure was then completed using another of the same device.There were no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: investigation results: based on the available information, boston scientific could confirm the reported event of stent partially deployed.An ultraflex esophageal stent has been returned for evaluation; the visual examination of the returned device found the stent partially deployed.The functional testing of the device was performed related to the deployment of the stent by pulling the finger ring.It was observed that the stent deployed without problem and there was no resistance felt.However, the suture was returned tangled.It is most likely related to procedural factors as lesion characteristics, handling of the device, the technique used by the physician, could have resulted in the damages encountered in the device, these damages could have unable to deploy the stent during the procedure causing the partially deployed encountered during the product analysis.Device history review: a review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Device technical analysis: visual examination of the device found the stent partially deployed.The functional testing of the device was performed related to the deployment of the stent by pulling the finger ring.It was observed that the stent deployed without problem and there was no resistance felt.However, the suture was returned tangled.Risk review: a risk review of the ultraflex esophageal stents was completed and confirmed that the event of stent partially deployed were defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted in the esophagus to treat an 8cm stenosis caused by cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was removed from the patient partially covered with the stent-deployment suture.The procedure was then completed using another of the same device.There were no patient complications reported as a result of 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: 24196056
• Report Number: 3005099803-2026-00327
• Device Sequence Number: 9649244
• Product Code: ESW
• UDI-Device Identifier: 08714729716167
• UDI-Public: (01)08714729716167(17)260123(10)33276372
• 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
• Report Date (Section B): 03/30/2026

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: 01/23/2026
• Device Model Number: M00513740
• Device Catalogue Number: M00513740
• Device Lot Number: 0033276372
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 03/01/2026
• Initial Report FDA Received Date: 01/27/2026
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/24/2024
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 60 KG