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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 21 FLOW DIVERTER

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MICROVENTION, INC. FRED 21 FLOW DIVERTER Back to Search Results
Model Number FRED3021-PMA
Device Problem Difficult to Remove (1528)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/26/2020
Event Type  malfunction  
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 delivery pusher was returned for evaluation. Upon initial investigation of the pusher, it did not appear to be straight. The reported complaint is non-verifiable as the stent wasn't returned to determine if it would get caught. The root cause of this complaint may have been due to tortuous anatomy causing the pusher to become stuck on the stent during removal. It may have also resulted in the pusher not being straight due to the tortuosity. The investigation of the returned pusher found no condition that would have directly resulted in the reported event.
 
Event Description
It was reported that treatment was performed for an anterior communicating artery (acom) aneurysm. The origin of the acom complex was reported to be slightly tortuous with some narrowing near the neck of the aneurysm. After placement of the fred between the a2 and a1 segment, the pusher wire caught on the stent during the removal attempt. The intermediate catheter was advanced and used to detach the stent from the pusher wire and microcatheter. After deployment, the fred slightly extended into the internal carotid artery. The stent remains implanted. No additional intervention was performed and there was no patient injury.
 
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Brand NameFRED 21
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 Key10320702
MDR Text Key202027902
Report Number2032493-2020-00182
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 12/17/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED3021-PMA
Device Lot Number19052753AM
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/18/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/27/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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