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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 MV-F402627
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Speech Disorder (4415); Thrombosis/Thrombus (4440)
Event Date 07/29/2021
Event Type  Injury  
Manufacturer Narrative
A search for non-conformance's 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 remains implanted in the patient and procedure images were not provided; therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies aphasia, stent thrombosis, as potential complications associated with use of the device.
 
Event Description
It was reported that the fred flow divert stent was implanted to treat an aneurysm in the left internal carotid artery. After four coils were implanted in the aneurysm with balloon assist, the fred was implanted with confirmed good apposition and the procedure was completed without post-ballooning. About two hours later, aphasia occurred and mri revealed an occlusion in the left internal carotid artery, which required emergency treatment. The thrombus in the stent was aspirated from the proximal side, but recanalization was not achieved completely and resulted in migration of the stent. The fred was retrieved with a snare and an embolization device from another manufacturer was implanted and the procedure was completed. The physician believes the patient will recover without any sequelae.
 
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Brand NameFRED 27
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 Key12363339
MDR Text Key268035842
Report Number2032493-2021-00354
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
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
Report Date 07/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F402627
Device Lot Number20042355W
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 Received07/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2020
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: 08/24/2021 Patient Sequence Number: 1
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