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

Model Number	H74938047940130
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a small hole in the packaging occurred.A 9.0x40x135 cm express ld stent balloon expandable was selected for use.Upon opening the device, a small hole was noticed in the outer packaging, which compromised the sterility of the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003.
Additional Manufacturer Narrative
H6 - evaluation method codes: updated.H6 - evaluation conclusion codes: updated.G4 - premarket / 510(k) #: k133110, p0900030.
Event or Problem Description
It was reported that a small hole in the packaging occurred.A 9.0x40x135 cm express ld stent balloon expandable was selected for use.Upon opening the device, a small hole was noticed in the outer packaging, which compromised the sterility of the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• 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: 24004887
• Report Number: 2124215-2026-01261
• Device Sequence Number: 13065282
• Product Code: NIO
• UDI-Device Identifier: 08714729392507
• UDI-Public: (01)08714729392507(17)270422(10)33871874
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2026

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: H74938047940130
• Device Catalogue Number: H74938047940130
• Device Lot Number: 0033871874
• 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: 12/16/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 01/08/2026
• Supplement Report FDA Received Date: 02/10/2026
• Date Device Manufactured: 04/22/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Race: White