MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27; FLOW DIVERTER

Model Number MV-F501427

Device Problem Activation Failure (3270)

Patient Problem Thrombus (2101)

Event Date 07/13/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformance associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was not returned to the manufacturer for investigation.The root cause cannot be determined.The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.

Event Description

It was reported that treatment was performed for an aneurysm.The fred stent was successfully placed without incident at the intended treatment site.After stent deployment, cone beam ct imaging demonstrated a little gap between the stent and the vessel, and a little calcification was seen in the proximal part of the aneurysm neck.During advancement of a balloon intended to dilate the vessel, stent shortening was observed before the guide wire or balloon could reach the stent.Angiography demonstrated a thrombotic occlusion of the internal carotid artery and effient 20mg was orally administered to the patient.The stent was removed from the patient with a gooseneck snare and blood flow was completely restored (tici3).There was no reported health damage or sequela.

Manufacturer Narrative

Corrected data: completed address.

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo, ca
• MDR Report Key: 10397081
• MDR Text Key: 202578829
• Report Number: 2032493-2020-00199
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121944
• UDI-Public: (01)04987892121944(11)200117(17)221231(10)200117553
• Combination Product (y/n): N
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2022
• Device Model Number: MV-F501427
• Device Lot Number: 200117553
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention