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

Model Number	M00513730
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	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6); reported here as it exceeded the 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 into the esophagus to treat a severe stenosis caused by a malignant tumor during an esophageal stent placement procedure performed on (b)(6) 2026.The anatomy of the patient was not tortuous and was dilated prior to stent placement.During procedure, the device was unable to be deployed normally.When the stent was removed from the patient it was partially deployed.The procedure was completed using another of the same device.There was no patient complications reported as a result of the procedure.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6) hospital; (b)(6); ((b)(6) hospital); reported here as it exceeded the character limit for the designated field.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: investigation summary: based on the available information, boston scientific corporation did not confirm the reported event of stent partially deployed.The stent was returned in an undeployed condition and functional testing demonstrated that the stent deployed without difficulty.However, an expansion issue was noticed during deployment.Stent expansion rates can be negatively affected by several external factors, including compression, time, temperature, and humidity.These conditions can influence how the stent behaves once it is released from the catheter delivery system.Stent expansion rates are seen most predominantly in the largest stent sizes, which experience the highest compression conditions while in the catheter delivery system.The larger the stent diameter, the more it is "packed" into the catheter of the delivery system.This means the stent will be compressed more and is more likely to have an unconstrained opening dimension that is smaller than the manufacturing specification.Device history record (dhr) review: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: an ultraflex esophageal ng distal release covered stent was received for analysis in an undeployed condition.Functional testing was conducted by actuating the finger ring to evaluate stent deployment.The stent deployed smoothly without resistance.However, an expansion issue was observed during deployment.No additional damage or abnormalities were identified in the stent or delivery system.Risk review: a review of the ultraflex esophageal stent dfmea was completed and confirmed that the event of stent partially deployed was 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 no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an ultraflex esophageal stent was to be implanted into the esophagus to treat a severe stenosis caused by a malignant tumor during an esophageal stent placement procedure performed on (b)(6) 2026.The anatomy of the patient was not tortuous and was dilated prior to stent placement.During procedure, the device was unable to be deployed normally.When the stent was removed from the patient it was partially deployed.The procedure was completed using another of the same device.There was 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: 24470644
• Report Number: 3005099803-2026-00766
• Device Sequence Number: 10308927
• Product Code: ESW
• UDI-Device Identifier: 08714729716150
• UDI-Public: (01)08714729716150(17)270220(10)35898629
• 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): 04/10/2026

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 Model Number: M00513730
• Device Catalogue Number: M00513730
• Device Lot Number: 0035898629
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2026
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 02/27/2026
• Supplement Report FDA Received Date: 04/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 68 YR
• Patient Sex: Male
• Patient Weight: 80 KG