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

Model Number 39200

Device Problem Migration (4003)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Event Description

It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.

Event Description

It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.

Manufacturer Narrative

Bsc aware date: (b)(6)2020.

Manufacturer Narrative

Bsc aware date: 02 dec 2020.

Event Description

It was reported that stent migration occurred.The target lesion was located in the right common iliac artery.A 10x40x75 epic vascular stent was advanced and deployed.The stent jumped about a centimeter after it was deployed.The lesion was fully covered and the procedure was completed.No patient complications were reported and patient's status was fine.

• Brand Name: EPIC VASCULAR
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11003944
• MDR Text Key: 221548573
• Report Number: 2134265-2020-17558
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729805014
• UDI-Public: 08714729805014
• Combination Product (y/n): N
• PMA/PMN Number: P110035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 01/05/2021

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: 0025948990
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2020
• Initial Date FDA Received: 12/14/2020
• Supplement Dates Manufacturer Received: 12/15/2020; 12/21/2020
• Supplement Dates FDA Received: 12/29/2020; 01/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1