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U.S. Department of Health and Human Services

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

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MICROVENTION, INC. FRED FLOW DIVERTER Back to Search Results
Model Number FRED5514-A
Device Problem Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/23/2021
Event Type  malfunction  
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 device was implanted in the patient and not returned to the manufacturer for analysis. Medical imaging was provided by the hospital for review, which does confirm the twisting of the stent. However, without the return and physical evaluation of the device, the investigation could not determine if a condition existed with the fred that would have caused or contributed to the reported event.
 
Event Description
It was reported that during deployment of a fred stent, it did not open properly in the curve of a vessel. Using the radiopaque markers as a visual guide, the stent appeared to be twisted. The vessel was checked for permeability and was noted to be "correct. " no medical or surgical intervention was performed. There was no reported patient injury or sequelae.
 
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Brand NameFRED
Type of DeviceFLOW DIVERTER
Manufacturer (Section D)
MICROVENTION, INC.
35 enterprise
aliso viejo CA 92656
Manufacturer Contact
terry callahan
35 enterprise drive
aliso viejo, CA 92656
MDR Report Key11600521
MDR Text Key243376007
Report Number2032493-2021-00103
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeSP
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
Report Date 03/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/31/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberFRED5514-A
Device Lot Number181218524
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 Received03/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/18/2018
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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