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

Model Number	H74939200126020
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1 - (b)(6).Device evaluated by mfr: the epic device was returned to our post market quality assurance laboratory.A visual and tactile examination identified multiple inner sheath kinks.The device was received with the stent partially deployed.This epic device is recommended for use with a 0.035" (0.89mm) guidewire as per label specifications.During the product analysis, the investigator was unable to advance the guidewire through the device due to the inner sheath kinks.The guidewire used by the customer was not returned for analysis.A visual examination identified no issues with the tip of the device or damage to the handle of the device.The safety lock was in place on the rack of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 28oct2025.It was reported that shaft kinked occurred.The target lesion was located in the iliac artery.The patient has a challenging anatomy.A 12x60x120 epic stent self-expanding was selected for angioplasty of iliac artery.During the procedure, the physician found that the tip of the delivery device was kinked, and the guide wire could not cross the delivery device.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a partially deployed stent.
Additional Manufacturer Narrative
B5.Describe event or problem: added information, based on additional information correction to a1: patient identifier.E1 - initial reporter address 1: (b)(6).E1 - initial reporter phone: (b)(6).Device evaluated by mfr: the epic device was returned to our post market quality assurance laboratory.A visual and tactile examination identified multiple inner sheath kinks.The device was received with the stent partially deployed.This epic device is recommended for use with a 0.035" (0.89mm) guidewire as per label specifications.During the product analysis, the investigator was unable to advance the guidewire through the device due to the inner sheath kinks.The guidewire used by the customer was not returned for analysis.A visual examination identified no issues with the tip of the device or damage to the handle of the device.The safety lock was in place on the rack of the device.This concludes the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 28oct2025.It was reported that shaft kinked occurred.The target lesion was located in the iliac artery.A 12x60x120 epic stent self expanding was selected for angioplasty of iliac artery.During the procedure, the physician found that the tip of the delivery device was kinked, and the guide wire could not cross the delivery device.The procedure was completed with another of the same device.There were no patient complications as a result of this event.However, device analysis revealed a partially deployed stent.It was further reported that the stent was deployed inadvertently during transit.

• 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: 23633656
• Report Number: 2124215-2025-84057
• Device Sequence Number: 21161545
• Product Code: NIO
• UDI-Device Identifier: 08714729805182
• UDI-Public: (01)08714729805182(17)250923(10)26076381
• 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
• Report Date (Section B): 12/04/2025

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 Expiration Date: 09/23/2025
• Device Model Number: H74939200126020
• Device Catalogue Number: H74939200126020
• Device Lot Number: 0026076381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/28/2025
• Supplement Date Received by Manufacturer: 11/09/2025
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2020
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 69 KG