• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICROVENTION, INC. FRED 27 FLOW DIVERTER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

MICROVENTION, INC. FRED 27 FLOW DIVERTER Back to Search Results
Model Number MV-F452827
Device Problem Material Separation (1562)
Patient Problems Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Event Date 10/13/2020
Event Type  Injury  
Manufacturer Narrative
A search for non-conformance's 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. A procedure video was provided for review; however, the fred stent was not clearly visible. A slight filling defect is noted in the proximal parent artery. The device was implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed. The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.
 
Event Description
It was reported that after the fred was deployed to treat a right internal carotid artery (ica) aneurysm, an occlusion of the ica occurred. A separation ("floating") of the inner layer of the proximal stent was identified by angiography. Another stent was implanted to overlap the fred. The patient was asymptomatic and there was no reported sequela. One-week post-procedure, an occlusion within the stent was identified by mri imaging. No intervention was performed. The patient was asymptomatic and there was no reported sequela. The patient's condition was reported to be "not serious. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10988913
MDR Text Key220898805
Report Number2032493-2020-00366
Device Sequence Number1
Product Code OUT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P180027
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberMV-F452827
Device Lot Number200423565
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 Received11/10/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/23/2020
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: 12/10/2020 Patient Sequence Number: 1
-
-