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

Model Number	39202
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (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 3mm from the distal end of the middle sheath.Microscopic examination revealed no damages.The lock for the rack is missing.It was considered likely that the partial deploy was attributable to handling.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis did not find any kinks on the device.
Event or Problem Description
Reportable based on device analysis completed on 21-sep-2020.It was reported that shaft kink occurred.The 99% stenosed target lesion was located in a severely tortuous and severely calcified shunt.An 8x100x75mm epic stent was selected for use.However, when the device was taken out, the shaft was found bent.The procedure was completed with a different device.There were no patient complications reported.However, returned device analysis revealed stent partial deployment.

• 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: 10593192
• Report Number: 2134265-2020-13347
• Device Sequence Number: 19766900
• Product Code: NIO
• UDI-Device Identifier: 08714729805571
• UDI-Public: 08714729805571
• 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
• Report Date (Section B): 09/28/2020

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: 11/09/2024
• Device Model Number: 39202
• Device Catalogue Number: 39202
• Device Lot Number: 0024751619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2020
• Initial Report FDA Received Date: 09/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1