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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 FRED2520-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Neurological Deficit/Dysfunction (1982); Thrombus (2101)
Event Date 06/01/2020
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 evaluation, as the stent remains implanted. The root cause could not be determined. The instructions for use (ifu) identifies vessel stenosis or occlusion and neorologic deficits including stroke and/or death as potential complications associated with use of the device.
 
Event Description
It was reported that the fred was successfully implanted in the anterior cerebral artery (aca) with no resheathing or device manipulations, and the fred opened appropriately. The patient had been anticoagulated prior to the procedure and anticoagulation was maintained during the case. The patient awoke post-procedure with aphasia and right-sided weakness, and approximately two (2) hours later was taken back to the procedure room. Dsa imaging confirmed aca hypoperfusion and a complete occlusion of the fred. Integrilin was administered, but without success; therefore, another stent was implanted within the fred, which resulted in only a minimal improvement to vessel patency. The patient was reported to have had a major stroke and is disabled.
 
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Brand NameFRED 21
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key10216039
MDR Text Key197176390
Report Number2032493-2020-00151
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 06/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED2520-PMA
Device Lot Number19031252CM
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 Received06/01/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/12/2019
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: 06/30/2020 Patient Sequence Number: 1
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