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

Model Number	39200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8x30x120 epic vascular stent was selected for use; however, when the device was taken out from the hoop, it was noted that the stent was partially deployed.Another of the same product with a different size was used and completed the procedure.No patient complications 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: 9473409
• Report Number: 2134265-2019-15751
• Device Sequence Number: 2903236
• Product Code: NIO
• UDI-Device Identifier: 08714729805625
• UDI-Public: 08714729805625
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2019

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: 09/07/2020
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022800858
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2019
• Initial Report FDA Received Date: 12/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1