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

Model Number	H74939200124070
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified abdominal aorta.A 12x40x75 epic was selected for use.During the procedure, when the stent was prepared and attempted to be advanced along the guidewire, it was noted that the tip appeared to be lifted.The procedure was completed with a different device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in the moderately tortuous and moderately calcified abdominal aorta.A 12x40x75 epic was selected for use.During the procedure, when the stent was prepared and attempted to be advanced along the guidewire, it was noted that the tip appeared to be lifted.The procedure was completed with a different device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
E1: initial reporter first name: updated.H6 - evaluation method codes and evaluation conclusion codes: updated.

• 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: 24152090
• Report Number: 2124215-2026-04138
• Device Sequence Number: 8969893
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: (01)08714729805151(17)300610(10)36729366
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2026

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: H74939200124070
• Device Catalogue Number: H74939200124070
• Device Lot Number: 0036729366
• 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: 12/25/2025
• Supplement Date Received by Manufacturer: 01/21/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/19/2026
• Date Device Manufactured: 06/11/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: GUIDEWIRE - TERUMO RADI FOCUS; GUIDEWIRE - TERUMO RADI FOCUS; INTRODUCER SHEATH - 6F TERUMO; INTRODUCER SHEATH - 6F TERUMO
• Patient Sex: Unknown