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

Model Number	39200
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/07/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that marking band issues occurred.A 10x80x120mm epic stent was selected for a percutaneous stent implantation.During the procedure, the proximal marker band of the delivery system could not be visualized.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an epic balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed kinks on the inner lumen 2.1cm and 7.4cm from the tip.Microscopic examination revealed no additional damages.The stent was fully deployed and did not return with the device.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that marking band issues occurred.A 10x80x120mm epic stent was selected for a percutaneous stent implantation.During the procedure, the proximal marker band of the delivery system could not be visualized.The procedure was completed with another of the same device.No patient complications were reported and patient status was stable.

• 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: 8175899
• Report Number: 2134265-2018-64425
• Device Sequence Number: 1326905
• Product Code: NIO
• UDI-Device Identifier: 08714729805083
• UDI-Public: 08714729805083
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 01/30/2019

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: 03/28/2022
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0020462955
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Initial Date Received by Manufacturer: 12/10/2018
• Supplement Date Received by Manufacturer: 01/10/2019
• Initial Report FDA Received Date: 12/18/2018
• Supplement Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 79 YR
• Patient Weight: 158