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

Model Number	H74938047720130
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	11/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x20x135 cm express ld iliac / biliary balloon expanding was selected for use in a leg angiogram.During insertion, it was noted that the stent came off balloon.Another 7.0x20x135 cm express ld iliac / biliary balloon expanding was used, however same issue occurred.The procedure was completed with a non-boston scientific device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
G4: premarket / 510(k) #:k133110, p090003.
Additional Manufacturer Narrative
G4: premarket / 510(k) #: k133110, p090003.Device evaluated by mfr: the express ld was returned for analysis.An examination of the crimped stent identified that the proximal and distal end of the stent was noted to be damaged, and the stent was noted to be pushed in a proximal direction passed the proximal markerband.Fibers was noted to be attached to the proximal end of the stent.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.A visual and tactile examination identified no issues with the shaft and tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent dislodgement occurred.A 7.0x20x135 cm express ld iliac / biliary balloon expanding was selected for use in a leg angiogram.During insertion, it was noted that the stent came off balloon.Another 7.0x20x135 cm express ld iliac / biliary balloon expanding was used, however same issue occurred.The procedure was completed with a non-boston scientific 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: 23720231
• Report Number: 2124215-2025-87041
• Device Sequence Number: 21384634
• Product Code: NIO
• UDI-Device Identifier: 08714729392439
• UDI-Public: (01)08714729392439(17)280225(10)35935358
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/18/2026

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: H74938047720130
• Device Catalogue Number: H74938047720130
• Device Lot Number: 0035935358
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2025
• 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