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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-F501427
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Visual Impairment (2138); Visual Disturbances (2140)
Event Date 08/27/2020
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances associated with this 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 identifies visual impairment as a potential complication associated with use of the device.
 
Event Description
It was reported that a fred 27 stent was implanted in the left internal carotid artery-ophthalmic region on (b)(6) 2020. Aspirin and clopidogrel (dapt) were administered to the patient post-procedure. Three days post-procedure, the patient developed visual field defects and impairment of the left eye progressed. The patient underwent steroid pulse therapy, and oral medication was continued after discharge. As of (b)(6) 2021, the symptoms have improved to the extent that they do not affect the patient's daily life.
 
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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
MDR Report Key11632191
MDR Text Key244376241
Report Number2032493-2021-00123
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 04/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F501427
Device Lot Number20012956R
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/29/2020
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: 04/07/2021 Patient Sequence Number: 1
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