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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 Stenosis (2263); Obstruction/Occlusion (2422); Vascular Dissection (3160); Ischemia Stroke (4418)
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 stenosis of stented segment 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, stenosis of 50% at the 12-month follow-up was observed in six patients. Two of the six patients with stenosis were symptomatic, and three of the six had complete parent artery occlusions. The symptomatic patient with complete occlusion presented at day 345 with multiple territory thromboembolic strokes. The second patient with symptomatic stenosis had embolic strokes on the day of treatment but recovered to nihss and mrs scores of 0 by day 30, although kinking and severe stenosis of the device was noted at angiographic follow-up. The four remaining patients were asymptomatic, although two of these patients had complete parent artery occlusions thought to be due to carotid artery dissections. ".
 
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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 Key12364146
MDR Text Key268050804
Report Number2032493-2021-00344
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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