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

Model Number	H74939200104020
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/02/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred the 90% stenosed target lesion was located in the severely tortuous and severely calcified subclavian artery of the thoracic aortic aneurysm.A 10x40x120 epic vascular was selected for use.During advancing, it was noted that the device could not cross the lesion and had a mark of kink in the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was received with the stent sheathed on the device.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified an outer sheath kink approximately 35mm proximal from the distal tip.A visual examination identified no issues or damage to the handle of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred the 90% stenosed target lesion was located in the severely tortuous and severely calcified subclavian artery of the thoracic aortic aneurysm.A 10x40x120 epic vascular was selected for use.During advancing, it was noted that the device could not cross the lesion and had a mark of kink in the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.
Additional Manufacturer Narrative
A1 - patient identifier: added.E1 - initial reporter zip code: added.Device evaluated by mfr: the device was received with the stent sheathed on the device.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified an outer sheath kink approximately 35mm proximal from the distal tip.A visual examination identified no issues or damage to the handle of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent damage occurred.The 90% stenosed target lesion was located in the severely tortuous and severely calcified subclavian artery of the thoracic aortic aneurysm.A 10x40x120 epic vascular was selected for use.During advancing, it was noted that the device could not cross the lesion and had a mark of kink in the stent.The procedure was completed with another of the same device.There were no patient complications as a result of this event and the patient status was stable post procedure.

• 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: 22457203
• Report Number: 2124215-2025-43674
• Device Sequence Number: 12816581
• Product Code: NIO
• UDI-Device Identifier: 08714729805007
• UDI-Public: (01)08714729805007(17)290417(10)33851928
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 11/19/2025

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: H74939200104020
• Device Catalogue Number: H74939200104020
• Device Lot Number: 0033851928
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/12/2025
• Supplement Date Received by Manufacturer: 07/24/2025; 10/22/2025
• Initial Report FDA Received Date: 07/09/2025
• Supplement Report FDA Received Date: 08/19/2025; 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2024
• 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: 56 YR
• Patient Sex: Male