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

Model Number	39200
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that removal difficulty was encountered.The target lesion was located in the iliac artery.An 8x40x75 epic vascular stent was advanced but failed to cross the lesion.The device was stuck and when it was removed, it was kinked due to pressure.The procedure was completed with a different device.There were no patient complications nor injuries reported and the patient was good.

• 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: 9985884
• Report Number: 2134265-2020-05443
• Device Sequence Number: 3700622
• Product Code: NIO
• UDI-Device Identifier: 08714729805656
• UDI-Public: 08714729805656
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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: 04/25/2022
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0020571148
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/13/2020
• Initial Report FDA Received Date: 04/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR