• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
Model Number FRED4518-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Blurred Vision (2137); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 03/31/2020
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances associated with the reported 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 implanted in the patient and not returned to the manufacturer for evaluation. Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed. The instructions for use identifies thrombosis and visual impairment as potential complications associated with use of the device.
 
Event Description
It was reported that during implantation of the fred to treat a left ophthalmic artery aneurysm, a filling defect was noted at the proximal end of the stent and the ophthalmic artery closed down. Integrilin was given, which restored flow. Six months post-procedure, a filling defect was still present at the proximal end of the stent and the ophthalmic artery was closed. The patient was reported to have blurred vision in the left eye. There was no reported device malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise
aliso viejo, CA 92656
MDR Report Key10844823
MDR Text Key216411069
Report Number2032493-2020-00332
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 11/16/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED4518-PMA
Device Lot Number19042253QM
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/22/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/16/2020 Patient Sequence Number: 1
-
-