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

Model Number	39200
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Age at time of event: 18 years or older.
Event or Problem Description
It was reported that stent positioning/placement problems were encountered.Vascular access was obtained via the right common femoral vein (ivc).The 90% stenosed target lesion was located in the moderately tortuous inferior vena cava.After a 7fr sheath was inserted, a 0.035inc x 150 cm non-bsc guide wire was advanced to cross the lesion.A 12mm x60mm x75cm epic vascular stent was advanced for treatment.However, upon deployment, the stent was placed in a position shifted to the center side from the lesion.The physician was grabbing the delivery shaft by finger and the stent was deployed by push-in.The stent stopped moving on the center side of the ivc, and it was decided to monitor the status.A 12mm x60mm x120cm epic vascular stent was additionally placed with the used of a 0.035inc x 300cm non-bsc guide wire and the procedure was completed.No patient complications were reported and the 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: 8147119
• Report Number: 2134265-2018-63731
• Device Sequence Number: 2118439
• Product Code: NIO
• UDI-Device Identifier: 08714729805199
• UDI-Public: 08714729805199
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/27/2022
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0020345179
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2018
• Initial Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention