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

Model Number	H74939200094070
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent jumping occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified left common iliac artery.A 9x40x75 epic stent self-expanding was selected for use.During the procedure, stent jumping occurred.The procedure was completed with this device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent jumping occurred.The 99% stenosed target lesion was located in the severely tortuous and severely calcified left common iliac artery.A 9x40x75 epic stent self-expanding was selected for use.During the procedure, stent jumping occurred.The procedure was completed with this device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device history record: it was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Labeling review: review of the instructions for use (ifu) confirmed that the content was sufficient and did not contribute to the reported event; therefore, no updates are required to the document at this time.Risk review: a risk review performed for the epic device confirmed that the reported event is a known event defined in the product's risk management documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefits for the product.Investigation conclusion: this investigation is assigned a conclusion code of cause traced to intentional off-label, unapproved, or contraindicated use because of the severe calcification and tortuosity of the patient anatomy.The epic stent system is contraindicated in such cases as the problematic anatomy can contribute to failure modes such as the deployment issue in the present 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: 24497230
• Report Number: 2124215-2026-11661
• Device Sequence Number: 10638271
• Product Code: NIO
• UDI-Device Identifier: 08714729805793
• UDI-Public: (01)08714729805793(17)300205(10)35799767
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: H74939200094070
• Device Catalogue Number: H74939200094070
• Device Lot Number: 0035799767
• 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: 02/02/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/02/2026
• Date Device Manufactured: 02/06/2025
• 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