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

Model Number 39202

Device Problems Difficult to Advance (2920); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/21/2024

Event Type  malfunction  

Event 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 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procedure.It was further reported that the stent could not arrived at the lesion and was not deployed.The stent was withdrawn directly.

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 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
• Type of Device: 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
• MDR Text Key: 341132788
• Report Number: 2124215-2024-21977
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805205
• UDI-Public: 08714729805205
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 03/31/2024
• Initial Date FDA Received: 04/26/2024
• Supplement Dates Manufacturer Received: 05/05/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 78 KG