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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 FRED4007-PMA
Device Problem Migration (4003)
Patient Problems Intracranial Hemorrhage (1891); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 03/10/2021
Event Type  Death  
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 analysis. Additionally, procedural images were not provided; therefore, the reported event cannot be confirmed. The instructions for use identifies death and device migration as potential complications associated with use of the device.
 
Event Description
It was reported that a fred 27 stent was placed for the treatment of an unruptured anterior choroidal aneurysm. The fred stent was deployed successfully and appeared to have good wall apposition. On a final angiographic run, the fred was observed to be positioned roughly 2-3mm distal into the middle cerebral artery (mca) with slow flow. Additional angiographic runs revealed an occlusion of the mca due to thrombosis of the vessel. The physician attempted to remove and recapture the fred. An intraoperative bleed occurred during the manipulations within the blood vessel and the physician then coiled the ica to stop it. An external ventricular drain was placed to drain blood. The patient later passed away.
 
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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
MDR Report Key11646247
MDR Text Key244800441
Report Number2032493-2021-00130
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,Followup
Report Date 04/09/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED4007-PMA
Device Lot Number20072255Z
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 Received04/15/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured07/22/2020
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: 04/09/2021 Patient Sequence Number: 1
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