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 Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that stent partial deployment occurred.Vascular access was obtained via contralateral approach.The target lesion was located in the an iliac vein.Following dilatation with a balloon catheter, a 7x40x75 epic vascular stent was advanced for treatment.However, the shaft was kinked and could not be deployed.The physician attempted to deploy the stent by rotating the thumb wheel but the marker did not move.Upon rotating the thumb wheel several times, the marker moved for several millimeters and the stent was deployed partially.The device was removed as the stent was not deployed as much as the thumb wheel rotated.The lesion was dilated with the balloon catheter and the procedure was completed.No patient complications nor injuries were reported.

• 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: 10061577
• Report Number: 2134265-2020-06554
• Device Sequence Number: 14116831
• Product Code: NIO
• UDI-Device Identifier: 08714729805458
• UDI-Public: 08714729805458
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/15/2020

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: 09/30/2024
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024527772
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/08/2020
• Initial Report FDA Received Date: 05/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1