MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION Epic? Vascular; Stent, Iliac

Model Number	H74939200104070
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent partial deployment occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified right iliac artery.A 10x40x75 epic stent self-expanding was selected for use.During the procedure, pre-dilation was performed with a mustang balloon catheter via a contralateral leg approach, and it was confirmed that dilation was able to be performed.After that, a stent was inserted, and an attempt was made to deploy the stent by turning the handle at the lesion site, but the stent did not deploy even when the tip began to emerge.Dilation was attempted through the stent using a balloon, but the balloon could not be inserted within the stent, so it was discontinued.The device was removed, and there were no separation/breakage observed in the removed stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Event or Problem Description
It was reported that stent partial deployment occurred.The 99% stenosed target lesion was located in the moderately tortuous and moderately calcified right iliac artery.A 10x40x75 epic stent self-expanding was selected for use.During the procedure, pre-dilation was performed with a mustang balloon catheter via a contralateral leg approach, and it was confirmed that dilation was able to be performed.After that, a stent was inserted, and an attempt was made to deploy the stent by turning the handle at the lesion site, but the stent did not deploy even when the tip began to emerge.Dilation was attempted through the stent using a balloon, but the balloon could not be inserted within the stent, so it was discontinued.The device was removed, and there were no separation/breakage observed in the removed stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
A2 - age at time of event: 18 years or older.Investigation results: 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 there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.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: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to patient condition.

• 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 ; +1(763)494-1632
• MDR Report Key: 25673531
• Report Number: 2124215-2026-34963
• Device Sequence Number: 10448051
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: (01)08714729805014(17)301123(10)38031426
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/12/2026

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: H74939200104070
• Device Catalogue Number: H74939200104070
• Device Lot Number: 0038031426
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2026
• Supplement Date Received by Manufacturer: 07/15/2026
• Initial Report FDA Received Date: 06/30/2026
• Supplement Report FDA Received Date: 08/12/2026
• Date Device Manufactured: 11/24/2025
• 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: Balloon Catheter - Mustang.; Guidewire - Jupiter.
• Patient Sex: Unknown