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

Model Number	H74938046640750
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	09/30/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6).G4: premarket / 510(k) #: k133110, p090003.
Event or Problem Description
It was reported that stent moved on the balloon.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel mesenteric artery.A 6.0x40x75cm express ld was selected for use.During the procedure, the stent was placed over a guidewire, but the physician observed that the stent was too long for the lesion.While removing the stent system, under fluoroscopy, it was observed that the stent was coming off the balloon.The physician immediately stopped, then advanced the system forward to retrieve the stent and the procedure was completed using alternate device.The stent did not completely dislodge from the balloon.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
(b)(6).G4: premarket / 510(k) #: k133110, p090003.Device evaluated by mfr: the express ld device was returned to our post market quality assurance laboratory.A visual and tactile examination identified that the balloon was tightly folded and had not been subject to positive pressure.No issues was noted with the balloon material.The device was received with the stent separated from the balloon.The stent was noted to be damaged.A visual and tactile examination identified no issues with the shaft and tip of the device.This concludes the product analysis.
Event or Problem Description
It was reported that stent moved on the balloon.The 50% stenosed target lesion was located in the moderately tortuous and moderately calcified vessel mesenteric artery.A 6.0x40x75cm express ld was selected for use.During the procedure, the stent was placed over a guidewire, but the physician observed that the stent was too long for the lesion.While removing the stent system, under fluoroscopy, it was observed that the stent was coming off the balloon.The physician immediately stopped, then advanced the system forward to retrieve the stent and the procedure was completed using alternate device.The stent did not completely dislodge from the balloon.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: 23414458
• Report Number: 2124215-2025-76790
• Device Sequence Number: 10300018
• Product Code: NIO
• UDI-Device Identifier: 08714729392156
• UDI-Public: (01)08714729392156(17)280219(10)35889056
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 12/19/2025

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: H74938046640750
• Device Catalogue Number: H74938046640750
• Device Lot Number: 0035889056
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2025
• 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 Age: 76 YR
• Patient Sex: Male