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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
Model Number FRED5014-PMA
Device Problem Activation Failure (3270)
Patient Problem Obstruction/Occlusion (2422)
Event Date 09/15/2020
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 the manufacturing of the device. The device was implanted in the patient and was not returned to the manufacturer; therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that upon deployment of the fred in the right internal carotid artery (ica), the stent was not fully opened. The anterior cerebral artery (aca) and the ica shut down. A balloon was inflated within the stent, which fully opened the stent and restored flow to the aca and ica.
 
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Brand NameFRED 27
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 Key10688083
MDR Text Key211628128
Report Number2032493-2020-00287
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED5014-PMA
Device Lot Number19101653WM
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 Received09/15/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/16/2019
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: 10/15/2020 Patient Sequence Number: 1
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