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

Model Number	H74938046730750
Medical Device Problem Codes	Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
G4 - premarket / 510(k) #: k133110, p090003.
Event or Problem Description
It was reported that the stent dislodged, requiring intervention.The target lesion was located in the tortuous and severely calcified ostial stenosis of the celiac artery.Vascular access was obtained via the right common femoral artery to the celiac artery.A 6f non-boston scientific guide sheath was placed, and a 7.0 x 30 x 75 cm express ld stent balloon expandable was advanced for treatment over.035 wire.It was noted that the guide sheath was only partially into the celiac artery, and an attempt was made to advance the balloon/stent over the wire and past the lesion.However, when advancing, the balloon pushed forward, causing the wire to lose access in the celiac artery, and move forward in the aorta.When attempting to pull back the stent into the sheath, the stent dislodged from the balloon shaft.A snare was used to pull the stent back to the common femoral artery; however, a surgical cutdown was performed to remove the stent.The procedure was cancelled, and the patient was under local anesthesia.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: 21945293
• Report Number: 2124215-2025-25072
• Device Sequence Number: 15543347
• Product Code: NIO
• UDI-Device Identifier: 08714729579663
• UDI-Public: (01)08714729579663(17)270415(10)33824094
• Combination Product (Y/N): N
• Initial Reporter State: VT
• 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
• Report Date (Section B): 05/01/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74938046730750
• Device Catalogue Number: H74938046730750
• Device Lot Number: 0033824094
• 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: 04/02/2025
• Initial Report FDA Received Date: 05/01/2025
• Date Device Manufactured: 04/15/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SHEATH: 6F TOUR GUIDE SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown