MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	H74938046940750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that dislodgement occurred.A 9.0x40x75cm express ld sent balloon expandable was selected for use.During the procedure, the device was inserted and it was observed that the stent was not attached to the balloon catheter.The detached stent was reportedly found on the scrub table while the team was preparing.The issue was not present upon opening the package.The procedure was then completed using with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis: the device was not received for analysis, as it was disposed of by the healthcare facility; therefore, product analysis could not be performed.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review was performed for the express ld iliac / biliary device and confirmed that the event of stent - dislodged outside the patient 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.Conclusion: boston scientific concludes the most probable root cause as unintended use error caused or contributed to event.It was reported that dislodgement occurred outside the patient.The device was not returned for analysis.The timing of the observed event and the fact that the stent was found in the preparation area, indicate that the stent was inadvertently removed from the delivery system during unpacking or preparation.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24519577
• Report Number: 2124215-2026-12256
• Device Sequence Number: 8430345
• Product Code: NIO
• UDI-Device Identifier: 08714729392330
• UDI-Public: (01)08714729392330(17)270604(10)34164972
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2026

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: H74938046940750
• Device Catalogue Number: H74938046940750
• Device Lot Number: 0034164972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/05/2026
• Date Device Manufactured: 06/04/2024
• 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