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

Model Number	H74938046740750
Medical Device Problem Codes	Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 7.0 x 40 x 75 cm express ld stent balloon was selected for use.Upon preparation, it was observed that the stent was not mounted on the balloon prior to use, and stent damage was noted.The affected device was not used for treatment.The procedure was completed successfully using an alternate device.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported that stent dislodgement occurred.The target lesion was located in the iliac artery.A 7.0 x 40 x 75 cm express ld stent balloon was selected for use.Upon preparation, it was observed that the stent was not mounted on the balloon prior to use, and stent damage was noted.The affected device was not used for treatment.The procedure was completed successfully using an alternate device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003 device evaluation by manufacturer: the device was returned for analysis.Visual and tactile inspection revealed that the balloon remained tightly folded with no evidence of prior inflation or exposure to positive pressure, and no abnormalities were observed in the balloon material.Examination of the crimped stent showed that it had been received already detached from the balloon and was noted to be damaged.Further visual and tactile evaluation identified no abnormalities in the device shaft or tip.Device history records (dhr) review: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that 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 reported event is a known event defined in the products risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product investigation conclusion: boston scientific concludes the most probable root cause as unintended use error caused or contributed to event.It was reported that the stent was found to be loose and displaced from the balloon catheter during preparation for the procedure.There was no report of device damage, defect, or malfunction during use, and the device was not returned for analysis.Review of the instructions for use found device handling and preparation precautions listed as potential contributing factors, suggesting the reported event is consistent with unintended use error caused or contributed to 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: 24388565
• Report Number: 2124215-2026-09286
• Device Sequence Number: 10279022
• Product Code: NIO
• UDI-Device Identifier: 08714729392217
• UDI-Public: (01)08714729392217(17)280221(10)35910066
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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: H74938046740750
• Device Catalogue Number: H74938046740750
• Device Lot Number: 0035910066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2026
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 02/19/2026
• Supplement Report FDA Received Date: 04/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2025
• 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
• Patient Sex: Unknown