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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 4.5X25X18 FLOW DIVERTER

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MICROVENTION, INC. FRED 4.5X25X18 FLOW DIVERTER Back to Search Results
Model Number FRED4518-A
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/28/2020
Event Type  malfunction  
Manufacturer Narrative
A search for non-conformance's 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 and the alleged product issue cannot be confirmed.
 
Event Description
It was reported that after deployment of the fred stent at the treatment site, the delivery system would not release from the stent. During additional maneuvers to release the stent, the fred was moved from the original site of placement in the vessel. There was no reported patient injury or additional intervention.
 
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Brand NameFRED 4.5X25X18
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 Key10497033
MDR Text Key206349065
Report Number2032493-2020-00240
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/08/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberFRED4518-A
Device Lot Number190723522
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 Received09/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/23/2019
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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