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

Model Number	H74939200106070
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty occurred.Vascular access was via a right common femoral artery (cfa) contralateral approach.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.A 10x60x75 epic self-expanding stent was selected for use.During the procedure, angle of the abdominal aortic bifurcation was steep, the guiding sheath was achieved up to pre-dilation, though navigation was challenging.When introducing the device, resistance and stiffness were noted, prompting careful manipulation; however, it could not reach the lesion.Attempts to retrieve the device failed, requiring removal of both the device and guidewire together.Examination revealed a fractured proximal shaft, rendering the device unusable.There was no procedural factors contribute to the reported event.The procedure was completed with a different device.There were no patient complications as the result of this event.
Additional Manufacturer Narrative
H6 - evaluation conclusion codes: updated.
Event or Problem Description
It was reported that removal difficulty occurred.Vascular access was via a right common femoral artery (cfa) contralateral approach.The 95% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery.A 10x60x75 epic self-expanding stent was selected for use.During the procedure, angle of the abdominal aortic bifurcation was steep, the guiding sheath was achieved up to pre-dilation, though navigation was challenging.When introducing the device, resistance and stiffness were noted, prompting careful manipulation; however, it could not reach the lesion.Attempts to retrieve the device failed, requiring removal of both the device and guidewire together.Examination revealed a fractured proximal shaft, rendering the device unusable.There was no procedural factors contribute to the reported event.The procedure was completed with a different device.There were no patient complications as the 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: 23822331
• Report Number: 2124215-2025-91243
• Device Sequence Number: 9386412
• Product Code: NIO
• UDI-Device Identifier: 08714729805052
• UDI-Public: (01)08714729805052(17)290809(10)34611287
• 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): 01/21/2026

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: H74939200106070
• Device Catalogue Number: H74939200106070
• Device Lot Number: 0034611287
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2025
• Supplement Date Received by Manufacturer: 12/23/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/21/2026
• Date Device Manufactured: 08/10/2024
• 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