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

Model Number 39200

Device Problem Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/20/2020

Event Type  malfunction  

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 2mm from the distal end of the sheath.There is a kink to the inner liner 23mm from the tip.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no other damage or irregularities.Product analysis found damage to the device that could have contributed to the reported event.

Event Description

Reportable based on device analysis completed on 14-jan-2021.It was reported that difficulty tracking over the guidewire occurred.The 100% stenosed target lesion was located in the moderately tortuous and severely calcified left common iliac artery to external iliac artery.A 9x80x75 epic vascular stent was advanced over a non-boston scientific guidewire outside the patient's body, but resistance was felt.The procedure was completed with another of same device.No patient complications nor injuries were reported.However, returned device analysis revealed stent partial deployment.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11207721
• MDR Text Key: 227975416
• Report Number: 2134265-2021-00504
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805878
• UDI-Public: 08714729805878
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/21/2021

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
• Device Operator: Health Professional
• Device Model Number: 39200
• Device Catalogue Number: 39200
• Device Lot Number: 0025585904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2021
• Initial Date FDA Received: 01/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE USED (HIRATA EGOIST 0.035)