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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-F451827
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 10/20/2020
Event Type  Injury  
Manufacturer Narrative
The lot number was not provided; therefore, a search for production-related ncrs could not be performed. The device was implanted in the patient and not returned to the manufacturer for evaluation. Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed. The instructions for use identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that after deployment of the fred, in-stent thrombosis occurred and recanalization treatment was performed. Four days post-procedure, the vessel re-occluded and a decompressive craniectomy was performed. There was no reported device malfunction.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise
aliso viejo, CA 92656
MDR Report Key10953648
MDR Text Key219957427
Report Number2032493-2020-00361
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,Followup
Report Date 02/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F451827
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 Received01/07/2021
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: 12/05/2020 Patient Sequence Number: 1
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