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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 FRED5029-PMA
Device Problems Difficult to Remove (1528); Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/22/2020
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 evaluation. The root cause of the complaint cannot be determined.
 
Event Description
It was reported that treatment was attempted for an internal carotid artery aneurysm. The patient's anatomy was reported to be very tortuous. The proximal finished ends of the fred were deployed at the neck of the aneurysm. An attempt was made to re-access the proximal end of the device with a microcatheter and the fred was pushed into the aneurysm sac. Multiple attempts were then made to remove the fred using a guide wire and a snare device, including accessing the contralateral femoral artery to reach the fred through the acom artery. All attempts were unsuccessful and the fred was left implanted in the aneurysm. There was no reported patient injury.
 
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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 Key10311955
MDR Text Key199984063
Report Number2032493-2020-00173
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 06/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED5029-PMA
Device Lot Number20031155A
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 Received06/22/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2020
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: 07/22/2020 Patient Sequence Number: 1
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