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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21 FLOW DIVERTER

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MICROVENTION, INC. FRED 21 FLOW DIVERTER Back to Search Results
Model Number FRED2513-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Muscle Weakness (1967); Thrombosis/Thrombus (4440)
Event Date 08/13/2021
Event Type  Injury  
Manufacturer Narrative
A search for non-conformances 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 not available for analysis; therefore, the alleged product issue cannot be verified. The instructions for use (ifu) identifies stent thrombosis and stenosis of stented segment as potential complications associated with use of the device.
 
Event Description
It was reported that during unspecified procedure, the fred flow diverter stent was positioned and deployed without issue. Immediate cta run looked good, and the vessel looked patent. Subsequent delayed runs showed progressive slower flow with eventual zero patency of vessel and intra-arterial integrelin was administered. Reportedly, the anatomy was challenging with some tortuosity to overcome and some vasospasm was noted and treated during the procedure. Post procedure the patient was stable with slight left side weakness.
 
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Brand NameFRED 21
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 Key12455239
MDR Text Key271130891
Report Number2032493-2021-00374
Device Sequence Number1
Product Code OUT
UDI-Device Identifier00842429106587
UDI-Public(01)00842429106587(11)200929(17)230831(10)20092957N
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED2513-PMA
Device Lot Number20092957N
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 Received10/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/27/2020
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: 09/10/2021 Patient Sequence Number: 1
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