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

Model Number	H74939200108020
Medical Device Problem Codes	Premature Activation (1484); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent premature deployment occurred, requiring intervention.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 8x80x120 epic vascular self-expanding stent was advance to treat the dissection.However, the stent deployed early when it arrived at the lesion site.The safety lock was removed from the handle prior to positioning the device in the lesion.Another stent was placed to complete the procedure, and there were no patient complications as a result of this event.The patient condition following procedure was stable.
Additional Manufacturer Narrative
D4: lot number and unique identifier (udi) #: corrected lot number, and therefore, udi, based on good faith effort (gfe) received.
Event or Problem Description
It was reported that stent premature deployment occurred, requiring intervention.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 8x80x120 epic vascular self-expanding stent was advance to treat the dissection.However, the stent deployed early when it arrived at the lesion site.The safety lock was removed from the handle prior to positioning the device in the lesion.Another stent was placed to complete the procedure, and there were no patient complications as a result of this event.The patient condition following procedure was stable.
Event or Problem Description
It was reported that stent premature deployment occurred, requiring intervention.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified superficial femoral artery.A 8x80x120 epic vascular self-expanding stent was advance to treat the dissection.However, the stent deployed early when it arrived at the lesion site.The safety lock was removed from the handle prior to positioning the device in the lesion.Another stent was placed to complete the procedure, and there were no patient complications as a result of this event.The patient condition following procedure was stable.
Additional Manufacturer Narrative
D4: lot number and unique identifier (udi) #: corrected lot number, and therefore, udi, based on good faith effort (gfe) received.Device evaluated by mfr: the epic was returned for analysis.A visual and tactile examination identified multiple inner sheath kinks.The device was received with the stent already deployed from the delivery system.A visual examination identified no issues with the tip of the device.A visual examination identified no issues or damage to the handle of the device.

• 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: 22338998
• Report Number: 2124215-2025-38889
• Device Sequence Number: 13017825
• Product Code: NIO
• UDI-Device Identifier: 08714729805083
• UDI-Public: (01)08714729805083(17)280624(10)31896025
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 08/28/2025

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: H74939200108020
• Device Catalogue Number: H74939200108020
• Device Lot Number: 0031896025
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 07/17/2025; 08/20/2025
• Initial Report FDA Received Date: 06/26/2025
• Supplement Report FDA Received Date: 08/14/2025; 08/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 60 KG