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

Model Number	H74938046860750
Medical Device Problem Code	Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003.Device evaluated by mfr: the express ld was returned for analysis.The first two rows of the proximal stent struts were found to be lifted/damaged.The recommended introducer sheath size for this express ld device as per ifu is a 7fr sheath.The investigator was unable to insert the device into a boston scientific introducer sheath as the stent was damaged, and more interaction could damage the device further.A visual examination of the returned device confirmed that the balloon was tightly folded and had not been subjected to positive pressure.No issues were noted with the balloon material.No issues were noted with the tip of the device.No other issues were identified with the device.
Event or Problem Description
Reportable based on device analysis completed on 25nov2025.It was reported that stent was difficult to insert.An 8.0x60x75cm express ld stent was selected for use in an iliac stenting procedure.During the procedure, stent was prepared according to standard procedure but could not be introduced into the non-boston scientific sheath.There was no visible damage to the device upon opening the package.The procedure was completed with another of the same device.There were no patient complication as the result of this event.However, device analysis revealed that the first two rows of the proximal stent struts were found to be lifted/damaged.

• 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: 23861096
• Report Number: 2124215-2025-92212
• Device Sequence Number: 4706460
• Product Code: NIO
• UDI-Device Identifier: 08714729392293
• UDI-Public: (01)08714729392293(17)260330(10)31345519
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Report Date (Section B): 12/21/2025

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: 03/30/2026
• Device Model Number: H74938046860750
• Device Catalogue Number: H74938046860750
• Device Lot Number: 0031345519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2023
• 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