MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EPIC? VASCULAR; STENT, ILIAC

Model Number	H74939200084070
Medical Device Problem Codes	Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device became stuck.The 75% stenosed target lesion was located in the moderately tortuous and moderately calcified right external iliac artery.An 8 x 40 x 75 epic stent self-expanding was selected for endovascular treatment to treat lower extremity artery disease.During the procedure, a contralateral approach was used.After placement with a non-boston scientific introducer sheath from the left femoral artery, the stent was advanced directly to the lesion part.However, the tip of the stent got stuck during advancement, which resulted in a kink from the mid-shaft towards the side of the tip.The physician could not fully determine where it got stuck and kinked as the stent advanced quickly.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.

• Brand Name: EPIC? VASCULAR
• 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: 23437822
• Report Number: 2124215-2025-78044
• Device Sequence Number: 4783223
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: (01)08714729805656(17)290724(10)34505884
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/31/2025

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: H74939200084070
• Device Catalogue Number: H74939200084070
• Device Lot Number: 0034505884
• 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: 10/06/2025
• Initial Report FDA Received Date: 10/31/2025
• Date Device Manufactured: 07/25/2024
• 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: BALLOON CATHETER: MUSTANG 7-40; GUIDEWIRE: RADIFOCUS 035; INFLATION DEVICE: VISTA; INTRODUCER SHEATH: DESTINATION 6FR; STENT: EPIC
• Patient Sex: Unknown