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

Model Number	H74939200068020
Medical Device Problem Codes	Premature Activation (1484); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/12/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 6mmx80mmx120mm epic¿ stent was selected for use.However upon opening the package, it was noted that the tip of the stent was partially out of the delivery system.The device was not used and the procedure was completed with a 6mmx80mm innova stent.No patient complications were reported and the patient's status was stable.
Additional Manufacturer Narrative
The returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.No damage was noticed on the shaft.The tip area showed inner liner buckling damage.The stent was partially deployed approximately 1.54cm from the marker band.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).
Event or Problem Description
It was reported that inadvertent stent deployment occurred.A 6mmx80mmx120mm epic¿ stent was selected for use.However upon opening the package, it was noted that the tip of the stent was partially out of the delivery system.The device was not used and the procedure was completed with a 6mmx80mm innova stent.No patient complications were reported and the patient's status was stable.

• 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: 6654078
• Report Number: 2134265-2017-06087
• Device Sequence Number: 16526529
• Product Code: NIO
• UDI-Device Identifier: 08714729805366
• UDI-Public: (01)08714729805366(17)20180831(10)18313469
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2017

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: 08/31/2018
• Device Model Number: H74939200068020
• Device Catalogue Number: 39200-06802
• Device Lot Number: 18313469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2017
• Initial Date Received by Manufacturer: 05/31/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 06/20/2017
• Supplement Report FDA Received Date: 07/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1