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

Model Number	39200
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Code Available (3191)
Date of Event	10/17/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that stent positioning difficulty was encountered.An 8x80x120 epic vascular stent was advanced for treatment.However, during deployment of the stent, the stent jump significantly and missed the mark where it was supposedly be placed.The procedure was completed with an additional stent.There were no patient complications nor injuries reported and the patient was fine.
Event or Problem Description
It was reported that stent positioning difficulty was encountered.An 8x80x120 epic vascular stent was advanced for treatment.However, during deployment of the stent, the stent jump significantly and missed the mark where it was supposedly be placed.The procedure was completed with an additional stent.There were no patient complications nor injuries reported and the patient was fine.It was further reported that the 80% stenosed target lesion was located in the moderately tortuous and moderately calcified right common iliac artery.

• 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: 9280658
• Report Number: 2134265-2019-13342
• Device Sequence Number: 2685149
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: 08714729805724
• 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: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2020

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024126812
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/17/2019
• Supplement Date Received by Manufacturer: 12/16/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 01/02/2020
• 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