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

Model Number	H74939200101070
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device entrapment occurred.The 90% target lesion was located in a moderately tortuous and moderately calcified vessel of the iliac.A 10x100x75 epic vascular self-expanding was selected for use.During advancing along with a non-boston scientific guidewire, it became stuck.Upon removal, the guidewire could not be removed, so the device was removed together with the guidewire.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
With the available information, boston scientific concludes: device history record (dhr) review it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations that could have contributed to the reported event.Device technical analysis the device was discarded; therefore, a technical analysis could not be performed.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 was completed and confirmed that the events of wire lumen - difficult to track over wire and catheter - froze on wire were defined in the risk documentation and are documented accordingly in the prr.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion boston scientific concludes the most probable root cause as unable to exclude device problem because of the limited detail of the reported information, the absence of any clarifying details from follow-up communications, and the inability to examine the alleged device or the concomitant guidewire.In this case, an analysis of the returned devices would most likely be required to clarify the cause of the 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: rachel shields shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 24561039
• Report Number: 2124215-2026-13204
• Device Sequence Number: 13135398
• Product Code: NIO
• UDI-Device Identifier: 08714729805113
• UDI-Public: (01)08714729805113(17)301016(10)37732220
• 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
• Report Date (Section B): 03/10/2026

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: H74939200101070
• Device Catalogue Number: H74939200101070
• Device Lot Number: 0037732220
• 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: 02/10/2026
• Initial Report FDA Received Date: 03/10/2026
• Date Device Manufactured: 10/17/2025
• 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/RADIFOCUS
• Patient Sex: Unknown