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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-F351627
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Ischemia (1942); Cerebral Edema (4403); Thrombosis/Thrombus (4440)
Event Date 10/12/2020
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 was implanted in the patient and not returned to the manufacturer for evaluation. Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed. The instructions for use identifies thromboembolic event and neurological deficits as potential complications associated with use of the device.
 
Event Description
It was reported that the fred was implanted to treat a vertebral artery (va) aneurysm. The stent was deployed without incident and was completely apposed to the vessel wall. Several hours post-procedure, a cerebellar infarct occurred due to a posterior inferior cerebellar artery (pica) occlusion. An anticoagulant was administered, which resolved the thrombus and recanalized the pica. A decompressive craniotomy was performed for cerebral edema. The patient's condition is expected to be favorable with rehabilitation. There was no reported malfunction of the fred.
 
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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
aliso viejo, CA 92656
MDR Report Key10872516
MDR Text Key217326341
Report Number2032493-2020-00336
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F351627
Device Lot Number20012956A
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 Received10/20/2020
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: 11/19/2020 Patient Sequence Number: 1
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