MAUDE Adverse Event Report: MICROVENTION, INC. FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)

Model Number MV-F402627

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Visual Impairment (2138)

Event Date 10/26/2020

Event Type  Injury  

Manufacturer Narrative

A search for non-conformances 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.The instructions for use (ifu) identifies reduced visual acuity and visual impairment as potential complications associated with use of the device.

Event Description

It was reported the patient had visual field impairment due to unspecified aneurysm.On (b)(6) 2020, a fred flow diverter stent was implanted successfully across the aneurysm.Approximately one month after the implantation, the patient's visual field impairment and visual impairment became worse due to the optic nerve being compressed by the aneurysm as blood still flowed into the aneurysm.On (b)(6) 2021, a second fred was implanted successfully, after which visual field impairment did not deteriorate.Both stents were successfully implanted and there were no defects found in them.Steroid pulse therapy was performed.Patient outcome not provided and is unknown.

• Brand Name: FLOW RE-DIRECTION ENDOLUMINAL DEVICE (FRED)
• Type of Device: FRED
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12051981
• MDR Text Key: 257847628
• Report Number: 2032493-2021-00250
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 04987892121869
• UDI-Public: (01)04987892121869(11)200311(17)230228(10)20031155H
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P180027
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2023
• Device Model Number: MV-F402627
• Device Lot Number: 20031155H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2020
• 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
• Patient Outcome(s): Required Intervention