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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 FRED4513-A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Paresis (1998); Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 02/06/2021
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances associated with the reported 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 reported event cannot be confirmed. The instructions for use identifiesin-stent thrombosis as a potential complication associated with use of the device.
 
Event Description
It was reported that a patient enrolled in the frits clinical study was treated for an aneurysm located in the left internal carotid artery (supraclinoid segment). The aneurysm never ruptured and previously was treated with coiling. Treatment consisted of using a fred. The permeability of the parent artery at the end of the procedure remains without stenosis. At discharge the patient neurological evaluation was mrs score 0 "no symptom at all". On (b)(6) 2021, 88 days following the procedure, the patient was transferred to the emergency department. The patient had acute symptoms of dysarthria and hemiparesis in upper right limb. Brain ct confirmed occlusion of the stent. The patient had stopped clopidogrel intake on (b)(6) 2021. A mechanical thrombectomy was performed, the outcome is ongoing. The patient was reported to not be compliant when taking clopidogrel and stopped taking it on his own.
 
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Brand NameFRED
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 Key11457783
MDR Text Key239446436
Report Number2032493-2021-00064
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeAU
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED4513-A
Device Lot Number200219549
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 Received04/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/19/2020
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: 03/10/2021 Patient Sequence Number: 1
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