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

Model Number	H74939200081020
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that catheter entrapment occurred.The target lesion was located in the superficial femoral artery.A 8x100x120 epic¿ vascular stent was being deployed, however, the stent was difficult to deploy and got stuck halfway through deploying it.The physician was able to fully deploy the stent.Upon withdrawing the catheter, it was noted the inner part of the white tubing got stuck on the guidewire.The catheter and guidewire were removed together from the patient.Because wire access was lost, the case was ended prematurely without post dilating the implanted stent.There were no patient complications and the patient status was okay.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an epic self-expanding stent system.The shaft, tip and the remainder of the device were examined for damage.The guidewire was not returned in the device.Visual examination did show multiple kinks on the inner shaft portion of the device from the tip to 14cm proximal.The stent was not returned with the device.Product analysis attempted to load a test guidewire into the device; however, with the damage on the inner shaft the guidewire would not transcend through the device.It showed signs of stickiness and restriction.There was no evidence of any damage or irregularities contributing to the reported deployment difficulty, which could not be confirmed because the clinical circumstances could not be replicated.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is operational context as device performance was limited due to anatomical procedural factors.(b)(4).
Event or Problem Description
It was further reported that the guide wire was an 0.035 exchange j wire.

• 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: 6180824
• Report Number: 2134265-2016-11738
• Device Sequence Number: 994560
• Product Code: NIO
• UDI-Device Identifier: 08714729805564
• UDI-Public: (01)08714729805564(17)20191005(10)18999943
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P110035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2016

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: 10/05/2019
• Device Model Number: H74939200081020
• Device Catalogue Number: 39200-08102
• Device Lot Number: 18999943
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/01/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/16/2016
• Supplement Report FDA Received Date: 01/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1