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

Model Number	H74938046830750
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent dislodgement occurred and the procedure was cancelled.The target lesion was located in the iliac artery.A 8.0x30x75cm express ld balloon stent was used for procedure.During the procedure, it was observed that the stent dislodged from the delivery system and moved to the aorta.Attempts were made to snare and retrieve the stent, but these efforts were unsuccessful, as the stent could not be captured.The procedure was not completed and was cancelled.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4: premarket / 510(k) #:k133110, p090003.
Event or Problem Description
It was reported that stent dislodgement occurred and the procedure was cancelled.The target lesion was located in the iliac artery.A 8.0x30x75cm express ld balloon stent was used for procedure.During the procedure, it was observed that the stent dislodged from the delivery system and moved to the aorta.Attempts were made to snare and retrieve the stent, but these efforts were unsuccessful, as the stent could not be captured.The procedure was not completed and was cancelled.There were no patient complications as a result of this event.It was further reported that the iliac artery was calcified and there was resistance in the vessel upon advancing the stent system.There were no further attempts planned to remove the stent.

• 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: 22664790
• Report Number: 2124215-2025-51242
• Device Sequence Number: 7767576
• Product Code: NIO
• UDI-Device Identifier: 08714729579670
• UDI-Public: (01)08714729579670(17)270205(10)33345235
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 08/21/2025

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: H74938046830750
• Device Catalogue Number: H74938046830750
• Device Lot Number: 0033345235
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/25/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 08/21/2025
• Date Device Manufactured: 02/06/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown