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 Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was partly inadvertently deployed.An 8x60x120mm epic stent was prepared for use.However, when the device was checked during preparation, it was noted that the stent was protruding several millimeters from the tip without manipulation of the deployment mechanism.The procedure was completed with an 8mmx8mm epic stent and no patient complications were reported.
Event or Problem Description
It was reported that the stent was partly inadvertently deployed.An 8x60x120mm epic stent was prepared for use.However, when the device was checked during preparation, it was noted that the stent was protruding several millimeters from the tip without manipulation of the deployment mechanism.The procedure was completed with an 8mmx8mm epic stent and no patient complications were reported.
Additional Manufacturer Narrative
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 was partially deployed approximately 6mm from the tip.Microscopic examination revealed no additional damages.The handle to the pull grip was measured and the lock was still on the pull rack.The middle sheath was no longer sitting on top of the proximal end of the tip.Inspection of the remainder of the device presented no damage or irregularities.

• 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: 8604994
• Report Number: 2134265-2019-05146
• Device Sequence Number: 16898950
• Product Code: NIO
• UDI-Device Identifier: 08714729805687
• UDI-Public: 08714729805687
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/31/2019

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: 05/14/2023
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0022123136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Initial Date Received by Manufacturer: 04/24/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 05/13/2019
• Supplement Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1