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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21 FLOW DIVERTER

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MICROVENTION, INC. FRED 21 FLOW DIVERTER Back to Search Results
Model Number FRED3021-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative
A search for non-conformance's 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 implanted in the patient and not returned to the manufacturer for analysis. Additionally, procedural images were not provided; therefore, the alleged event cannot be confirmed. The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.
 
Event Description
It was reported that 12 hours after implantation of the fred in the supraclinoid segment of the ica, thrombus was identified in the artery. The patient experienced dysarthria. Reopro and heparin were administered to the patient. There was no reported malfunction of the fred.
 
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Brand NameFRED 21
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11042424
MDR Text Key224024690
Report Number2032493-2020-00378
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 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED3021-PMA
Device Lot Number19110154LM
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 Received11/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/05/2019
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: 12/18/2020 Patient Sequence Number: 1
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