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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED X27 FLOW DIVERTER

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MICROVENTION, INC. FRED X27 FLOW DIVERTER Back to Search Results
Model Number XFRED4017-MVE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Headache (1880); Loss of Vision (2139); Thrombosis/Thrombus (4440)
Event Date 04/24/2021
Event Type  Injury  
Event Description
It was reported that a fred x flow diverter stent was used to treat a patient with a communicating segment aneurysm on (b)(6) 2021 has thrombosed. This was sited from cavernous apex to immediately proximal to the bifurcation and has thrombosed through the proximal third to the level of the posterior communicating artery inflow (mri/mra & vaso-ct done to confirm). This resulted in severe visual impairment in the right eye. The patient reports meticulous adherence to the dual antiplatelet regimen, prasugrel and aspirin. 6 days later, the patient suffered sudden onset of headache and visual loss. Additional information indicated patient suffered from unidentified clotting problem.
 
Manufacturer Narrative
At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u. S. The complaint is being reported now as based on this product meeting similar product criteria. 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 is not available for return to the manufacturer for analysis, and procedure images were not provide. Therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies stent thrombosis, stenosis of stented segment, headache, blindness as potential complications associated with use of the device.
 
Manufacturer Narrative
At the time this complaint was received, this product was an exported device that was not cleared or approved for marketing in the u. S. The complaint is being reported now as based on this product meeting similar product criteria. 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 is not available for return to the manufacturer for analysis, and procedure images were not provide. Therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies stent thrombosis, stenosis of stented segment, headache, blindness as potential complications associated with use of the device.
 
Event Description
It was reported that a fred x flow diverter stent was used to treat a patient with a communicating segment aneurysm on (b)(6) 2021 has thrombosed. This was sited from cavernous apex to immediately proximal to the bifurcation and has thrombosed through the proximal third to the level of the posterior communicating artery inflow (mri/mra & vaso-ct done to confirm). This resulted in severe visual impairment in the right eye. The patient reports meticulous adherence to the dual antiplatelet regimen, prasugrel and aspirin. 6 days later, the patient suffered sudden onset of headache and visual loss. Additional information indicated patient suffered from unidentified clotting problem.
 
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Brand NameFRED X27
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 Key13066257
MDR Text Key285243112
Report Number2032493-2021-00522
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberXFRED4017-MVE
Device Lot Number20121815G
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/30/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2020
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: 12/22/2021 Patient Sequence Number: 1
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