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

Model Number	39202
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stent was implanted and will not be returned for analysis.However, an analysis was concluded based on the received photo of the complaint device.The photo of the outer packaging showed the epic size.The x-ray that was retuned shows a stent in the body, but no confirmation can be made from the x-ray that the stent was the incorrect size.No other issues were identified with the device and no patient complications were reported.
Event or Problem Description
It was reported that stent profile problem occurred.The target lesion was located in the superficial femoral artery (sfa).A 6x100x120 epic vascular stent was deployed and post-dilated with a non-boston scientific balloon; however, a visible size difference between the stent and a previously deployed 6x150 stent in the distal sfa was noted.The physician believes that the deployed stent had an incorrect size.The stent remained implanted; however, the stent did not fully cover target lesion.The procedure was completed.There were no complications reported and the patient was okay.Investigation completed on 19mar2024.The stent was implanted and will not be returned for analysis.However, an analysis was concluded based on the received photo of the complaint device.The photo of the outer packaging showed the epic size.The x-ray that was retuned shows a stent in the body, but no confirmation can be made from the x-ray that the stent was the incorrect size.No other issues were identified with the device and no patient complications were reported.
Additional Manufacturer Narrative
Investigation was completed on 19mar2024.The stent was implanted and will not be returned for analysis.However, an analysis was concluded based on the received photo of the complaint device.The photo of the outer packaging showed the epic size.The x-ray that was returned shows a stent in the body, but no confirmation can be made from the x-ray that the stent was the incorrect size.No other issues were identified with the device and no patient complications were reported.Reopened investigation was completed on 24apr2024.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 and tactile examination of the inner and outer sheath found multiple kinks.A visual examination identified no issues or damage to the handle of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent profile problem occurred.The target lesion was located in the superficial femoral artery (sfa).A 6x100x120 epic vascular stent was deployed and post-dilated with a non-boston scientific balloon; however, a visible size difference between the stent and a previously deployed 6x150 stent in the distal sfa was noted.The physician believes that the deployed stent had an incorrect size.The stent remained implanted; however, the stent did not fully cover target lesion.The procedure was completed.There were no complications reported and the patient was okay.

• 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: 18985381
• Report Number: 2124215-2024-13831
• Device Sequence Number: 14176782
• Product Code: NIO
• UDI-Device Identifier: 08714729805205
• UDI-Public: 08714729805205
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/17/2024

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 Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0030040246
• 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: 02/29/2024
• Supplement Date Received by Manufacturer: 04/24/2024
• Initial Report FDA Received Date: 03/27/2024
• Supplement Report FDA Received Date: 05/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2022
• 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 Sex: Unknown