MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EPIC¿ VASCULAR; STENT, ILIAC

Model Number	H74939200061220
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).It is indicated that the device will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is device not returned as the complaint did not include returned device review and lacked the objective evidence or descriptive conditions of the event required to determine what could have contributed to the event.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.During preparation for a stent treatment procedure within the iliac vein, the 6x120x120 epic vascular stent deployed on the table outside the patient's body.The procedure was completed with a different device.No patient complications were reported and the patient was reported to be fine post procedure.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7045707
• Report Number: 2134265-2017-11173
• Device Sequence Number: 19076956
• Product Code: NIO
• UDI-Device Identifier: 08714729805229
• UDI-Public: 08714729805229
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 08/07/2022
• Device Model Number: H74939200061220
• Device Catalogue Number: 39200-06122
• Device Lot Number: 20982797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1