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

Model Number	H74939200086070
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent premature deployment occurred.The 100% stenosed target lesion was located in the mildly tortuous and non-calcified portal vein.An 8x60x75 epic vascular stent self-expanding was selected for use.Upon insertion of the stent into the lesion through the 7fr sheath, the outer shaft retracted before reaching the target lesion, causing the stent to begin to deploy.The use of the stent was discontinued before it could be pressed against the vessel.The procedure was completed with another of the same device.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Device evaluated by mfr: the epic device was returned for evaluation.The device was received with the stent partially deployed.The investigator removed the safety lock and successfully deployed the stent without issue.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the sheath of the device.A visual examination identified no issues or damage to the handle of the device.The safety lock was in place on the rack of the device.The investigator opened the handle and no issues noted.No other issues were identified with the device.
Event or Problem Description
It was reported that stent premature deployment occurred.The 100% stenosed target lesion was located in the mildly tortuous and non-calcified portal vein.An 8x60x75 epic vascular stent self-expanding was selected for use.Upon insertion of the stent into the lesion through the 7fr sheath, the outer shaft retracted before reaching the target lesion, causing the stent to begin to deploy.The use of the stent was discontinued before it could be pressed against the vessel.The procedure was completed with another of the same device.There were no patient complications as a result of this 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 23660670
• Report Number: 2124215-2025-84209
• Device Sequence Number: 15751419
• Product Code: NIO
• UDI-Device Identifier: 08714729805694
• UDI-Public: (01)08714729805694(17)300619(10)36799597
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/16/2026

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: H74939200086070
• Device Catalogue Number: H74939200086070
• Device Lot Number: 0036799597
• 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: 10/30/2025
• Supplement Date Received by Manufacturer: 12/19/2025
• Initial Report FDA Received Date: 11/26/2025
• Supplement Report FDA Received Date: 01/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2025
• 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 - RADIFOCUS; GUIDEWIRE - RADIFOCUS
• Patient Sex: Unknown