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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 FRED3516-PMA
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Thrombosis/Thrombus (4440)
Event Date 12/02/2020
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 delivery pusher and microcatheter were returned; however, the stent was not returned for evaluation. Fluoroscopic images were provided for review, which confirmed the presence of thrombus within the stent and an occlusion of the mca, as reported. There is no obvious indication of deformity of the stent construct or incomplete expansion of the stent in the limited images provided. The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.
 
Event Description
It was reported that after deployment of the fred device in the internal carotid artery (ica), thrombus developed within the stent and the middle cerebral artery (mca) became occluded. Heparin was increased and tpa was administered, which improved flow in the mca. The fred device was successfully retrieved from the patient. There was no reported sequela.
 
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Brand NameFRED 27
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
eva manus
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11061543
MDR Text Key223380423
Report Number2032493-2020-00389
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 02/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Model NumberFRED3516-PMA
Device Lot Number20061755J
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/07/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/17/2020
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: 12/22/2020 Patient Sequence Number: 1
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