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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 FRED4017-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Thrombus (2101); Weakness (2145); Brain Injury (2219)
Event Date 03/02/2020
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 not returned to the manufacturer for analysis. The root cause cannot be determined,.
 
Event Description
It was reported that treatment was performed for a left internal carotid artery (ica) terminus aneurysm. The fred was successfully placed at the treatment site without incident and immediate angiograms demonstrated a patent fred. After completion of the case, the patient experienced right sided weakness and speech difficulties, and was returned for another angiogram, which demonstrated an occluded fred. Thrombus was aspirated through an intermediate catheter and balloon angioplasty was performed within the fred, which restored vessel patency. Post-procedure images confirmed a patent left ica, left middle cerebral artery, and fred. The patient was reported to be nearly back to baseline neuro status on (b)(6) 2020.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo, ca
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, ca 
MDR Report Key9914518
MDR Text Key190205615
Report Number2032493-2020-00081
Device Sequence Number1
Product Code OUT
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
Report Date 03/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED4017-PMA
Device Lot Number19030652WM
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 Received03/02/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/06/2019
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: 04/01/2020 Patient Sequence Number: 1
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