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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 5.0X26X19 FLOW DIVERTER

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MICROVENTION, INC. FRED 5.0X26X19 FLOW DIVERTER Back to Search Results
Model Number FRED5019-A
Device Problem Difficult to Fold, Unfold or Collapse (1254)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/13/2020
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, as it was implanted in the patient. The root cause cannot be determined.
 
Event Description
It was reported that treatment was performed on an aneurysm in the paraophthalmic segment of the left internal carotid artery. After placement at the treatment site, the proximal segment of the fred did not open. After resheathing, deployment was attempted again and the proximal segment opened slightly; however, the stent could not be withdrawn back into the microcatheter. The fred was manipulated with the microcatheter and a balloon catheter to open the proximal segment of the stent. Final checks post-procedure demonstrated patency of the vessels. The stent remains implanted. There was no reported patient injury.
 
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Brand NameFRED 5.0X26X19
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 Key9827518
MDR Text Key183274019
Report Number2032493-2020-00062
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
Report Date 02/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Model NumberFRED5019-A
Device Lot Number18112753R
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 Received02/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/27/2018
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: 03/12/2020 Patient Sequence Number: 1
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