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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 FRED4017
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Headache (1880); Convulsion/Seizure (4406); Hemorrhagic Stroke (4417); Ruptured Aneurysm (4436)
Event Type  Death  
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 not returned to the manufacturer for evaluation; therefore, the alleged event cannot be confirmed. The instructions for use (ifu) identifies headache, seizure, rupture or perforation of the aneurysm, hemorrhage, including intracranial hemorrhage, and death as potential complications associated with use of the device.
 
Event Description
As reported through the article titled, "flow redirection endoluminal device (fred) with or without adjunctive coiling in treatment of very large and giant cerebral aneurysms," published in clinical neuroradiology and reviewed by company on august 20, 2021: a patient presented with diplopia and left-sided loss of vision. Left ica angiogram revealed a 29× 27× 26mm sized left ica supraophthalmic segment aneurysm. The patient was treated with a fred stent and adjunctive coiling with total occlusion of the aneurysm sac. There was no intraventricular or subarachnoid hemorrhage on posttreatment ct. The patient developed sudden onset severe headache 17 hours after the procedure and ct showed diffuse subarachnoid hemorrhage extending into the prepontine cistern. The patient had a seizure followed by cardiac arrest while in the ct scanner. Immediately after resuscitation, ct revealed interval massive subarachnoid and intraventricular hemorrhage with hydrocephalus due to the second rupture. The patient later passed away. Several attempts to obtain additional case information were unsuccessful.
 
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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 Key12491919
MDR Text Key272104219
Report Number2032493-2021-00382
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 foreign,health professional,l
Reporter Occupation
Type of Report Initial
Report Date 08/20/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberFRED4017
Device Lot NumberUNKNOWN
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 Received08/20/2021
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

Patient Treatment Data
Date Received: 09/17/2021 Patient Sequence Number: 1
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