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

Model Number 39202

Device Problem Material Deformation (2976)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2020

Event Type  malfunction  

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 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
• 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: 10593192
• MDR Text Key: 208764572
• Report Number: 2134265-2020-13347
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805571
• UDI-Public: 08714729805571
• 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: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2019
• 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