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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 FRED3536-PMA
Device Problem Difficult or Delayed Activation (2577)
Patient Problem Thrombus (2101)
Event Date 08/06/2020
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 cannot be determined. The instructions for use (ifu) identifies vessel stenosis or thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that the fred was used as treatment for a tortuous m2 to m1 fusiform aneurysm with two curves. The fred was delivered smoothly; however, the proximal stent did not completely open upon deployment. Thrombus formation was observed inside the proximal portion of the fred. Integrilin was administered through the microcatheter at the proximal portion of the device. Aspiration was attempted, but was not successful. After multiple manipulations of the device with the microcatheter and microwire, the fred completely opened and the thrombus within the device was no longer visualized. No neurological deficits or abnormalities were observed during the post-procedure neurological exam of the patient. The patient is currently reported to be doing well.
 
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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 Key10495426
MDR Text Key205711832
Report Number2032493-2020-00241
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 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED3536-PMA
Device Lot Number190513558M
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 Received08/06/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/13/2019
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: 09/04/2020 Patient Sequence Number: 1
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