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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 UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Transient Ischemic Attack (2109); Thromboembolism (2654)
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 was not available for return to the manufacturer for analysis. Medical imaging was not available. Therefore, the reported event could not be confirmed. The instructions for use (ifu) identifies thromboembolic event and transient ischemic attack as potential complications associated with use of the device. Choi, jai ho, et al. "a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms. " yonsei medical journal 63. 4 (2022): 349.
 
Event Description
As reported through the article titled, "a single flow re-direction endoluminal device for the treatment of large and giant anterior circulation intracranial aneurysms" published in yonsei medical journal, a patient that was treated with a fred for an unruptured aneurysm (diameter 10. 1mm x neck size 9. 8mm) at the mca (middle cerebral artery) between january 2018 and july 2020 experienced a thromboembolic complication (tia) on postoperative date 176. The patient recovered without neurological deficit. The patient was a responder to: aspirin and clopidogrel.
 
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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 Key14151900
MDR Text Key289672949
Report Number2032493-2022-00164
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 03/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
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

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