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

Model Number	H74939200084070
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 10mm x 40mm x75 epic vascular stent with serial number (b)(6) was the other epic stent implanted; however, only one of the stents ro band had the issue.We completed a good faith effort to obtain additional complaint information.If additional details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a markerband issue occurred.The target lesion was located in the left iliac artery.A 10mm x 40mm x75 epic? vascular self-expanding stent was placed in the proximal iliac, followed by a 10mm x 50mm non-boston scientific stent placed distal to the first stent, and finally an 8x40x75 epic? vascular self-expanding stent was placed distal to the non-bsc stent.After stenting, angiography confirmed patent flow through the iliac artery with no concerns.However, a postoperative computed tomography (ct) scan revealed that one of the five radiopaque (ro) marker bands at the distal end of an epic stent appeared in the center of the vessel.This was noted to be abnormal based on imaging that the ro band would not be opposed to the vessel wall.There were no plans to remove the stents, and the patient was scheduled for duplex ultrasound in two weeks to confirm continued blood flow.There were no patient complications as a result of this event.

• 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: mark mischke ; 4100 hamline ave n; arden hills, MN 55112 ; 7634941632
• MDR Report Key: 25117923
• Report Number: 2124215-2026-24910
• Device Sequence Number: 9292981
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: (01)08714729805656(17)301115(10)37969578
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/15/2026

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: H74939200084070
• Device Catalogue Number: H74939200084070
• Device Lot Number: 0037969578
• 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: 04/13/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 05/07/2026
• Supplement Report FDA Received Date: 06/15/2026
• Date Device Manufactured: 11/16/2025
• 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