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

Model Number	H74939200088070
Medical Device Problem Codes	Difficult to Insert (1316); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent struts protruded.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.An 8x80x75 epic stent self-expanding was selected for use.During preparation, the stent protruded slightly accidently by the user and got caught on the y-connector, so it could not be inserted into the patient.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 the stent struts protruded.The 75% stenosed target lesion was located in the moderately tortuous and mildly calcified vessel.An 8x80x75 epic stent self-expanding was selected for use.During preparation, the stent protruded slightly accidently by the user and got caught on the y-connector, so it could not be inserted into the patient.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Investigation results: device evaluated by mfr: the epic device was returned to our post market quality assurance laboratory.The device was received with the stent partially deployed on the delivery system.No issues were found with the stent.A visual examination found no issues with the tip of the device.A visual and tactile examination found the inner sheath of the device to be kinked at more than one location.A visual examination found no issues or damage to the handle of the device.The safety lock was in place on the rack of the device.This concludes the product analysis.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 unintended use error caused or contributed to event based on the probability of the safety lock detaching from the device due to handling during preparation for the procedure.Premature removal of the safety lock would have led to the accidental partial deployment of the stent.It is most probable that the safety lock had displace from the device during preparation resulting in the stent beginning to inadvertently deploy and then replaced.This would have led to the difficulty advancing the device through the introducer sheath, which was confirmed during analysis.

• 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: 24226626
• Report Number: 2124215-2026-05645
• Device Sequence Number: 13077907
• Product Code: NIO
• UDI-Device Identifier: 08714729805731
• UDI-Public: (01)08714729805731(17)290720(10)34474889
• 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): 04/06/2026

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: H74939200088070
• Device Catalogue Number: H74939200088070
• Device Lot Number: 0034474889
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 01/30/2026
• Supplement Report FDA Received Date: 04/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2024
• 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