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

Model Number MV-F501927

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/15/2021

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 analysis; therefore, the alleged product issue cannot be confirmed.

Event Description

It was reported that upon deployment of the fred device to treat an aneurysm in the right internal carotid artery (ica), the device reportedly partially expanded.A balloon catheter was deployed to successfully expand the stent completely, which resulted in good flow through the stent.There was no reported patient injury.

Manufacturer Narrative

It was reported that the fred stent previously implanted in the patient was, on (b)(6) 2021, confirmed to have in-stent thrombosis when dsa was performed for a post-procedure follow-up.The patient is being observed and dapt with aspirin and clopidogrel was administered.The patient's condition was reported to be "not serious.".

• Brand Name: FRED 27
• Type of Device: FLOW DIVERTER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• MDR Report Key: 10610674
• MDR Text Key: 209326650
• Report Number: 2032493-2020-00273
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121951
• UDI-Public: (01)04987892121951(11)200129(17)221231(10)20012956T
• 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: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• 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-F501927
• Device Lot Number: 20012956T
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention