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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED FLOW DIVERTER Back to Search Results
Model Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Obstruction/Occlusion (2422); Vascular Dissection (3160); Ischemia Stroke (4418); Thrombosis/Thrombus (4440)
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances associated with the part/lot number combinations of the actual devices could not be performed, as the part and lot numbers were not provided. The devices were implanted in the patient and not returned to the manufacturer for analysis. Procedural or post-procedural images were not provided; therefore the reported event could not be confirmed. The instructions for use identifies stent thrombosis and stroke as potential complications associated with use of this device.
 
Event Description
As reported through the article titled, "safety and efficacy results of the flow redirection endoluminal device (fred) stent system in the treatment of intracranial aneurysms: us pivotal trial", after undergoing aneurysm treatment with a fred stent, 4 patients developed device thrombosis on post-treatment days 1, 3, 5 and 345. Three of these four delayed events were thought to be due to technical problems, including carotid dissection and kinking of the device, and the fourth, noted on day 345, was seen in the setting of multiple territory thrombo-embolic infarcts. Two of these four patients with delayed events had complete occlusion of the parent artery. ".
 
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Brand NameFRED
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 Key12364103
MDR Text Key268039105
Report Number2032493-2021-00343
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 literature
Reporter Occupation
Type of Report Initial
Report Date 07/26/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/25/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
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 Received07/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 08/25/2021 Patient Sequence Number: 1
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