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

Model Number	H74939200088020
Medical Device Problem Codes	Device Damaged Prior to Use (2284); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/06/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was not received for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.  (b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 8x80x120 epic¿ vascular stent was selected to treat the lesion.However, during preparation and upon flushing, the physician noted that the distal stent struts was exposed.The procedure was completed with a different device.No patient complications were reported.

• Brand Name: EPIC¿ VASCULAR
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• MDR Report Key: 6522459
• Report Number: 2134265-2017-04028
• Device Sequence Number: 340064
• Product Code: NIO
• UDI-Device Identifier: 08714729805724
• UDI-Public: (01)08714729805724(17)20210131(10)18771654
• 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
• Type of Report: Initial
• Report Date (Section B): 04/06/2017

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: 01/31/2021
• Device Model Number: H74939200088020
• Device Catalogue Number: 39200-08802
• Device Lot Number: 18771654
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2017
• Initial Report FDA Received Date: 04/26/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1