• 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 21 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 21 FLOW DIVERTER Back to Search Results
Model Number FRED2513-PMA
Device Problem Material Deformation (2976)
Patient Problems Obstruction/Occlusion (2422); Unspecified Tissue Injury (4559)
Event Date 04/23/2021
Event Type  Injury  
Manufacturer Narrative
The device was implanted in the patient and not returned to the manufacturer for evaluation. Procedural or post-procedural images were not provided for review; therefore, the alleged product issue cannot be confirmed. 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 instructions for use (ifu) identifies neurological deficit as a potential complication associated with use of the device.
 
Event Description
It was reported that a fred 21 stent was successfully deployed in the anterior cerebral artery and the aneurysm had stagnant flow. Eight days post procedure, cta showed that the vessel was not filling, the stent had compressed, and the patient had infarction in the region of treatment. The patient is now in rehabilitation and the physician predicts their condition should improve.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFRED 21
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terrence callahan
35 enterprise drive
aliso viejo, CA 92656
7142478000
MDR Report Key11898189
MDR Text Key253204823
Report Number2032493-2021-00189
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00842429106587
UDI-Public(01)00842429106587(11)201014(17)230930(10)20101454R
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 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED2513-PMA
Device Lot Number20101454R
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 Received04/27/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/07/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-