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

Model Number	39200
Medical Device Problem Code	Misassembled (1398)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that missing marker bands occurred.The target lesion was located in the biliary duct.A 10x80x75mm epic stent was opened however, prior to loading on the wire, it was noted that distal markers were missing.The procedure was completed with another of the same device.No patient complications were reported and patient status was good.
Event or Problem Description
It was reported that missing marker bands occurred.The target lesion was located in the biliary duct.A 10x80x75mm epic stent was opened however, prior to loading on the wire, it was noted that distal markers were missing.The procedure was completed with another of the same device.No patient complications were reported and patient status was good.
Additional Manufacturer Narrative
(b)(6).Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer shaft, inner shaft, and tip were visually and microscopically examined.Visual examination revealed that the stent is partially deployed 1.5mm from the middle sheath.Microscopic examination revealed no additional damages.The lock is still on the rack.Inspection of the remainder of the device presented no other 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: 9376114
• Report Number: 2134265-2019-14446
• Device Sequence Number: 11529636
• Product Code: NIO
• UDI-Device Identifier: 08714729805090
• UDI-Public: 08714729805090
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 12/20/2019

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 Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0024177754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/12/2019
• Supplement Date Received by Manufacturer: 12/13/2019
• Initial Report FDA Received Date: 11/26/2019
• Supplement Report FDA Received Date: 12/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR