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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 FRED5514-PMA
Device Problems Material Twisted/Bent (2981); Activation Failure (3270)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/03/2020
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 analysis. The root cause cannot be determined,.

 
Event Description

It was reported that after the fred had been deployed in the supraclinoid internal carotid artery (ica), part of the stent did not appear to be opened. A wire, microcatheter, and a guide catheter were used to open the stent. Integrilin was administered to the patient during the procedure. Upon closer inspection post-procedure, the implanted stent appeared to be twisted in the proximal segment. There was no reported patient injury and the patient is reported to be in good condition.

 
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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 Key9918024
MDR Text Key191384879
Report Number2032493-2020-00076
Device Sequence Number1
Product Code OUT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberP180027
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 03/03/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/02/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator OTHER
Device MODEL NumberFRED5514-PMA
Device LOT Number19050754NM
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 Received03/03/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/07/2019
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: 04/02/2020 Patient Sequence Number: 1
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