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

Model Number	H74939200088070
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent partially deployed, requiring an additional device.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified external iliac artery.An 8x80x75 epic vascular stent self-expanding was selected for use.During the procedure, the stent was inserted into the blood vessels and crossed through the lesion once.As the stent deployed distally upon initiating deployment, it was attempted to pull the shaft for repositioning, however, the shaft got stuck.As a result, it had to be placed as it was, making it unable to cover the lesion.Subsequently, an additional stent was used in the same procedure, and it had been deployed successfully.There were no patient complications as a result of this event.
Additional Manufacturer Narrative
Corrections: b1: adverse event/product problem.B2: outcomes attrib to adv event.
Event or Problem Description
It was reported that stent partially deployed, requiring an additional device.The 95% stenosed target lesion was located in the mildly tortuous and mildly calcified external iliac artery.An 8x80x75 epic vascular stent self-expanding was selected for use.During the procedure, the stent was inserted into the blood vessels and crossed through the lesion once.As the stent deployed distally upon initiating deployment, it was attempted to pull the shaft for repositioning, however, the shaft got stuck.As a result, it had to be placed as it was, making it unable to cover the lesion.Subsequently, an additional stent was used with the same procedure, and it had been deployed successfully.There were no patient complications as a result of this event.It was further reported that the vessel lesion was pre-dilated prior to stent placement.Furthermore, the shaft appeared to be stuck within the vessel.The stent was deployed approximately 1 cm before being pressed against the vessel wall.Upon initiating deployment of the stent, there was no resistance encountered with the stent delivery system, and it appears to have been withdrawn without issue after deployment.

• 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: 23823812
• Report Number: 2124215-2025-91274
• Device Sequence Number: 9386454
• Product Code: NIO
• UDI-Device Identifier: 08714729805731
• UDI-Public: (01)08714729805731(17)300923(10)37530853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 01/08/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: H74939200088070
• Device Catalogue Number: H74939200088070
• Device Lot Number: 0037530853
• 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: 11/21/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/08/2026
• Date Device Manufactured: 09/24/2025
• 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: INTRODUCER SHEATH - TERUMO 6F 10CM; INTRODUCER SHEATH - TERUMO 6F 10CM
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown