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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 Activation Failure (3270)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 11/25/2020
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 analysis. Additionally, procedural images were not provided for review; therefore, the alleged device issue cannot be confirmed. The instructions for use identifies stent thrombosis as a potential complication associated with use of the device.
 
Event Description
It was reported that after implantation of the fred in the internal carotid artery (ica), the proximal end of the stent was not completely expanded. One-day post-procedure, thrombus was identified within the stent. Ozagrel and effient were administered to the patient, which recanalized the ica. There was no reported sequela.
 
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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 drive
aliso viejo, CA 92656
MDR Report Key11059476
MDR Text Key223362911
Report Number2032493-2020-00385
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 12/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
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 Received11/25/2020
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: 12/22/2020 Patient Sequence Number: 1
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