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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-F451827
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 09/08/2021
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 remains implanted in the patient and not available for analysis; therefore, the alleged product issue cannot be confirmed. If additional information is received, microvention, inc. Will issue a supplemental mdr report. The instructions for use (ifu) identifies thrombus as potential complications associated with use of the device.
 
Event Description
It was reported that a fred flow diverter stent and hydrosoft3d embolization coils were used to treat an internal carotid artery aneurysm (ica). Both the stent and coil were successfully deployed and positioned, and angiography showed no issues. Angiography was then performed again but the inside and distal part of the fred were not visible and in-stent thrombosis was suspected. 200mg of effient was administered before pta with a balloon was performed. Some stenosis remained, but recanalization was achieved. Patient had no neurological symptoms observed and was discharged. The physician commented that the sudden thrombosis might have been caused by the hydrosoft 3d coil, which the physician does not usually use and the clots in the aneurysm might be pushed out by coil. Reportedly, the patient had been taking aspirin 100mg and clopidogrel 75mg 8 days before the procedure. Teg was performed as a preoperative platelet coagulation test, and the results were ma-adp45. 3 and ma-aa20. 9 this is report 1 of 2 (ref: mfr. Report# 2032493-2021-00402).
 
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Brand NameFRED 27
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 Key12586924
MDR Text Key277750861
Report Number2032493-2021-00401
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 09/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMV-F451827
Device Lot Number20102856V
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 Received09/08/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/28/2020
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: 10/06/2021 Patient Sequence Number: 1
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