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

Model Number	39200
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/24/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 10 x 40 x 120 epic stent was prepared to be used for treatment.However, upon unpacking, it was noted that the stent was kinked and the tip was damaged.The procedure was completed using another device.There were no complications reported.
Additional Manufacturer Narrative
The epic device was returned for an analysis and it was received with the stent fully constrained in the correct position on the delivery system.The stent was unsheathed and was noted to be kinked approximately 20mm proximal from the distal tip.There were no issues reported with the tip of the device post visual examination; however, the visual and tactile examination found multiple kinks on the sheath along the length of the device.No issues or damage to the handle, and safety lock was in place.
Event or Problem Description
It was reported that stent damage occurred.A 10 x 40 x 120 epic stent was prepared to be used for treatment.However, upon unpacking, it was noted that the stent was kinked and the tip was damaged.The procedure was completed using another device.There were no complications reported.

• 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: 18169684
• Report Number: 2124215-2023-64589
• Device Sequence Number: 7652647
• Product Code: NIO
• UDI-Device Identifier: 08714729805007
• UDI-Public: 08714729805007
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2023

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: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0030493403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 11/24/2023
• Initial Report FDA Received Date: 11/20/2023
• Supplement Report FDA Received Date: 12/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/07/2022
• 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: 47 YR
• Patient Sex: Male