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

Model Number	H74938047830130
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred.The 80% stenosed lesion was located in the mildly tortuous and severely calcified peripheral artery.An 8.0 x 30 mm x 135 cm express ld iliac / biliary stent system was advanced; however, difficulty was encountered while advancing the device over the aortic arch.Upon crossing the calcified lesion, the stent dislodged from the delivery balloon.The stent migrated from the common iliac artery to the external iliac artery.The physician elected to keep the dislodged stent and used a balloon to expand it against the vessel wall at the external iliac artery within the diseased segment.The stent was not removed, as the physician determined it was acceptable to deploy it at that location.The procedure was completed without reported patient complications.
Additional Manufacturer Narrative
G4: premarket / 510(k): k133110, p090003.Good faith effort attempts were made to try and retrieve additional details regarding the reported event, but further information was unable to be obtained.
Additional Manufacturer Narrative
G4: premarket / 510(k): k133110, p090003.Device history record: 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.Labeling review: review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.Risk review: a risk review performed for the express ld device confirmed that the stent - dislodged inside the patient is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient anatomy and/ or condition.
Event or Problem Description
It was reported that stent dislodgement occurred requiring additional intervention.The 80% stenosed lesion was located in the mildly tortuous and severely calcified peripheral artery.An 8.0 x 30 mm x 135 cm express ld iliac / biliary stent system was advanced; however, difficulty was encountered while advancing the device over the aortic arch.Upon crossing the calcified lesion, the stent dislodged from the delivery balloon.The stent migrated from the common iliac artery to the external iliac artery.The physician elected to keep the dislodged stent and used a balloon to expand it against the vessel wall at the external iliac artery within the diseased segment.The stent was not removed, as the physician determined it was acceptable to deploy it at that location.The procedure was completed without reported patient complications.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 24689104
• Report Number: 2124215-2026-16322
• Device Sequence Number: 10041966
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: (01)08714729579700(17)280611(10)36739150
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74938047830130
• Device Catalogue Number: H74938047830130
• Device Lot Number: 0036739150
• 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: 02/25/2026
• Supplement Date Received by Manufacturer: 03/30/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/23/2026
• Date Device Manufactured: 06/12/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown