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

Model Number	H74939200124070
Medical Device Problem Codes	Unsealed Device Packaging (1444); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contamination occurred.A 12x40x75 epic vascular self-expanding was selected for use.During device preparation, it was noted that the plastic seal of the device was torn.There was no damage to the outer box.There was no patient involvement.
Event or Problem Description
It was reported that contamination occurred.A 12x40x75 epic vascular self-expanding was selected for use.During device preparation, it was noted that the plastic seal of the device was torn.There was no damage to the outer box.There was no patient involvement.It was further reported that the outer packaging of the product was torn, and since this was observed before opening the box, the sterility of the inner pouch or device could not be confirmed.
Additional Manufacturer Narrative
Investigation results: 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 review of 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 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 traced to transport/storage.
Event or Problem Description
It was reported that contamination occurred.A 12x40x75 epic vascular self-expanding was selected for use.During device preparation, it was noted that the plastic seal of the device was torn.There was no damage to the outer box.There was no patient involvement.It was further reported that the outer packaging of the product was torn, and since this was observed before opening the box, the sterility of the inner pouch or device could not be confirmed.

• 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: 23864264
• Report Number: 2124215-2025-92277
• Device Sequence Number: 18632784
• Product Code: NIO
• UDI-Device Identifier: 08714729805151
• UDI-Public: (01)08714729805151(17)300521(10)36581435
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/14/2026

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: H74939200124070
• Device Catalogue Number: H74939200124070
• Device Lot Number: 0036581435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2025
• Supplement Date Received by Manufacturer: 12/18/2025; 03/19/2026
• Initial Report FDA Received Date: 12/22/2025
• Supplement Report FDA Received Date: 01/15/2026; 04/14/2026
• Date Device Manufactured: 05/22/2025
• 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