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

Model Number	H74938047740130
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).
Event or Problem Description
It was reported that stent moved on balloon occurred.The 60% stenosed target lesion was located in the mild tortuous and moderately calcified iliac artery.A 7.0x40x135 cm express ld was selected for use.During the procedure, the stent was inserted through a bsc 11cm 6f sheath.It was noted that the stent could not cross the tight lesion.The stent was removed.The artery was pre-dilated with a bsc.035 balloon 5x40 successfully.The ld stent was reinserted through the sheath and crossed lesion.However, once the stent was position across the lesion, it was noted that the stent was halfway slide back on the it's balloon.The sheath was removed, and the ld stent catheter was removed from the body fully intact with balloon and stent 100% and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent moved on balloon occurred.The 60% stenosed target lesion was located in the mild tortuous and moderately calcified iliac artery.A 7.0x40x135 cm express ld was selected for use.During the procedure, the stent was inserted through a bsc 11cm 6f sheath.It was noted that the stent could not cross the tight lesion.The stent was removed.The artery was pre-dilated with a bsc.035 balloon 5x40 successfully.The ld stent was reinserted through the sheath and crossed lesion.However, once the stent was position across the lesion, it was noted that the stent was halfway slide back on the its balloon.The sheath was removed and the ld stent catheter was removed from the body fully intact with balloon and stent 100% and the procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr: the express ldwas returned for analysis.A visual examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues were noted with the balloon.The device was received without the stent attached to the balloon.A visual and tactile examination identified multiple shaft kinks.A visual and tactile examination identified no issues with tip of this device.

• 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: 23347886
• Report Number: 2124215-2025-74840
• Device Sequence Number: 9461244
• Product Code: NIO
• UDI-Device Identifier: 08714729392446
• UDI-Public: (01)08714729392446(17)270228(10)33527753
• 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
• 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): 12/16/2025

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 Model Number: H74938047740130
• Device Catalogue Number: H74938047740130
• Device Lot Number: 0033527753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2025
• Supplement Date Received by Manufacturer: 11/24/2025
• Initial Report FDA Received Date: 10/21/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/29/2024
• 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: Female