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

Model Number	H74939200068020
Medical Device Problem Codes	Contamination (1120); Incomplete or Missing Packaging (2312)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was not in a sealed sterile package.The target lesion was located in the right lower leg.A 6 x 80 x 120 epic vascular was selected for right lower leg angiography.However, it was noted that the stent was in an unopened box but not in a sealed sterile package.The device was immediately set aside as soon as the box was opened and was never introduced to 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
Good faith effort attempts were made to retrieve additional details regarding the device status, but further information was unable to be obtained.
Event or Problem Description
It was reported that the stent was not in a sealed sterile package.The target lesion was located in the right lower leg.A 6x80x120 epic vascular was selected for right lower leg angiography.However, it was noted that the stent was in an unopened box but not in a sealed sterile package.The device was immediately set aside as soon as the box was opened and was never introduced to 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
Media review: media was received in the form of images.Images were provided by the customer depicting the device inside the packaging tray and removed from all other packaging.It cannot be confirmed from the image if the inner pouch was present or not when the outer box carton was opened.Device technical analysis: upon receipt at our post market quality assurance laboratory, the device was returned with all packaging removed.The packaging was not returned for analysis.A visual and tactile examination found no kinks or damage to the sheath of the device.The device was returned with the stent in the correct position on the delivery system.No other issues were identified during the product analysis.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.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 event of device - not sterile and packaging - incomplete or missing packaging was defined in the risk documentation and is documented accordingly in the prr.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.

• 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: 23695620
• Report Number: 2124215-2025-85381
• Device Sequence Number: 9072052
• Product Code: NIO
• UDI-Device Identifier: 08714729805366
• UDI-Public: (01)08714729805366(17)290312(10)33625167
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2026

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: H74939200068020
• Device Catalogue Number: H74939200068020
• Device Lot Number: 0033625167
• 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: 11/05/2025
• Supplement Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 12/02/2025
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2024
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Race: White