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

Model Number	39200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.
Additional Manufacturer Narrative
Bsc aware date: (b)(6)2020.
Additional Manufacturer Narrative
Bsc aware date: 02 dec 2020.
Event or Problem Description
It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.

• Brand Name: EPIC VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11003944
• Report Number: 2134265-2020-17558
• Device Sequence Number: 10980167
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2021

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: 08/31/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025948990
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/02/2020
• Supplement Date Received by Manufacturer: 12/15/2020; 12/21/2020
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 12/29/2020; 01/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1