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

Model Number	39200
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in anastomosis of fistula.A 6x60x75 epic vascular stent was selected for use.However, the distal stent struts where the markers lie are slightly peeled away from the catheter prior to placement into the sheath.The procedure was completed with another of the same device.There were no patient complications 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 is partially deployed 1mm from the distal end of the middle sheath.There is a kink to the sheath 58.5cm from the nosecone.Microscopic examination revealed that the sheath is flattened at the distal end.Inspection of the remainder of the device presented no other damage or irregularities.
Event or Problem Description
It was reported that stent damage occurred.The target lesion was located in anastomosis of fistula.A 6x60x75 epic vascular stent was selected for use.However, the distal stent struts where the markers lie are slightly peeled away from the catheter prior to placement into the sheath.The procedure was completed with another of the same device.There were no patient complications 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: 11013105
• Report Number: 2134265-2020-17820
• Device Sequence Number: 3944734
• Product Code: NIO
• UDI-Device Identifier: 08714729805335
• UDI-Public: 08714729805335
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/22/2021

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: 08/27/2025
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025933746
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2020
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 01/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1