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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 MV-F453927
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 07/15/2021
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 evaluation. Post procedural images were not provided. Therefore, the reported event could not be confirmed. The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.
 
Event Description
It was reported that on (b)(6) 2021, a second fred of the same size was placed in the same location where the first fred had been placed to treat the ruptured aneurysm (ref mfr report#: 2032493-2021-00235). On (b)(6) 2021 one of the two medications, aspirin and prasugrel, was suspended (unknown which) and occlusion was confirmed on the same day. Thrombectomy was performed on the occlusion and recanalization was achieved. The patient resumed taking three medications (aspirin, prasugrel and cilostazol). Final value were aru 527 and pru 220.
 
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Brand NameFRED
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 Key12333566
MDR Text Key267045170
Report Number2032493-2021-00346
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 07/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F453927
Device Lot Number20012956L
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 Received07/27/2021
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: 08/17/2021 Patient Sequence Number: 1
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