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

Model Number	39202
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent migrated and did not fully cover the stenosis.The patient was presented with left femoral artery occlusion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6x100x120 epic vascular was advanced for treatment.However, the stent was difficult to deliver to the target position.When deployed, it was noted that the stent migrated and did not fully cover the stenosis.There was no additional intervention performed.No complications were reported, and the patient was stable post procedure.
Event or Problem Description
It was reported that stent migrated and did not fully cover the stenosis.The patient was presented with left femoral artery occlusion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6x100x120 epic vascular was advanced for treatment.However, the stent was difficult to deliver to the target position.When deployed, it was noted that the stent migrated and did not fully cover the stenosis.There was no additional intervention performed.No complications were reported, and the patient was stable post procedure.It was further reported that the stent could not arrived at the lesion and was not deployed.The stent was withdrawn directly.
Additional Manufacturer Narrative
The device was received with the stent fully constrained in the correct position on the delivery system.A visual examination identified no issues with the tip of the device.A visual and tactile examination found no kinks or damage to the shaft of the device.A visual examination identified no issues or damage to the handle of the device.The safety lock was in place on the rack of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent migrated and did not fully cover the stenosis.The patient was presented with left femoral artery occlusion.The 90% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 6x100x120 epic vascular was advanced for treatment.However, the stent was difficult to deliver to the target position.When deployed, it was noted that the stent migrated and did not fully cover the stenosis.There was no additional intervention performed.No complications were reported, and the patient was stable post procedure.It was further reported that the stent could not arrived at the lesion and was not deployed.The stent was withdrawn directly.

• 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: 19190875
• Report Number: 2124215-2024-21977
• Device Sequence Number: 8426303
• Product Code: NIO
• UDI-Device Identifier: 08714729805205
• UDI-Public: 08714729805205
• 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,Followup
• Report Date (Section B): 06/13/2024

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: 07/22/2026
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0027721933
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/31/2024
• Supplement Date Received by Manufacturer: 05/05/2024; 05/24/2024
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/22/2024; 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 78 KG