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

TPLC - Total Product Life Cycle

  • 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
 

New Search Back To Search Results
Device intracranial aneurysm flow diverter
Definition Treatment of wide-necked and larger or giant intracranial aneurysms.
Product CodeOUT
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 3 1 4 3 1 0

Device Problems
Failure to expand 167
No Known Device Problem 66
Break 18
Failure to deploy 16
Migration of device or device component 13
Detachment of device or device component 8
Flaked 2
Material separation 2
Detachment of device component 2
Device operates differently than expected 2
Retraction problem 2
Deployment issue 2
No code available 1
Difficult to remove 1
Physical resistance 1
Material deformation 1
Component falling 1
Slippage of device or device component 1
Total Device Problems 306

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1 0 1 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Oct-14-2015
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Aug-23-2013

-
-