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

Model Number	39201
Medical Device Problem Codes	Premature Activation (1484); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/28/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6 x 120 x 120 epic vascular stent was selected to treat the lesion.However, when the stent was opened, a malfunctioned tip was noted.The device was already deployed and never touched the patient.The procedure was completed using a different device.No patient complications were reported.
Additional Manufacturer Narrative
Initial reporter address (b)(6).Device evaluated by mfr.: 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.Visual examination revealed that the stent is partially deployed 9mm from the distal end of the middle sheath.The sheath is kinked 10.1cm from the distal end of the middle sheath.Microscopic examination revealed no additional damages.The yellow lock is still on the rack.The distal end of the middle sheath appears to have moved proximally because it is no longer sitting over the proximal end of the tip.
Event or Problem Description
It was reported that inadvertent deployment occurred.A 6 x 120 x 120 epic vascular stent was selected to treat the lesion.However, when the stent was opened, a malfunctioned tip was noted.The device was already deployed and never touched the patient.The procedure was completed using a different device.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: 8556763
• Report Number: 2134265-2019-04442
• Device Sequence Number: 2309036
• Product Code: NIO
• UDI-Device Identifier: 08714729805229
• UDI-Public: 08714729805229
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: 02/06/2022
• Device Model Number: 39201
• Device Catalogue Number: 39201
• Device Lot Number: 0020257367
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1