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

Model Number	39200
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).
Event or Problem Description
It was reported that stent partial deployment occurred.The patient presented with thoracic aortic aneurysm and underwent transcatheter aortic valve replacement (tvar).A 8x80x120 epic vascular stent was advanced over a 0.014 inch guidewire.However, during deployment, only a part of the stent was deployed despite multiple attempts.The stent was removed with the delivery system and the procedure was completed with another of same device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by manufacturer: epic vascular 8x80x120 was received for analysis.A visual examination found the stent of the device to have been deployed from the delivery system.The deployed stent was not returned for analysis.A visual and tactile inspection found the inner shaft of the device to be severely kinked at more than one location.This type of damage is consistent with excessive force being applied to the device.A visual and tactile examination identified no issues with the tip of the device.A visual examination found the handle of the device to be broken into two pieces.It is not known why the handle was broken.
Event or Problem Description
It was reported that stent partial deployment occurred.The patient presented with thoracic aortic aneurysm and underwent transcatheter aortic valve replacement (tvar).A 8x80x120 epic vascular stent was advanced over a 0.014-inch guidewire.However, during deployment, only a part of the stent was deployed despite multiple attempts.The stent was removed with the delivery system and the procedure was completed with another of same device.There were no patient complications reported.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15703843
• Report Number: 2124215-2022-41799
• Device Sequence Number: 8276987
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: 08714729805724
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 08/16/2026
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0027851155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/11/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 10/31/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2021
• 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 Sex: Unknown