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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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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 2017
0 0 0 0 3 1 4 3 1 1 0

Device Problems
Failure to expand 456
No Known Device Problem 346
Failure to deploy 50
Break 48
Migration of device or device component 45
Physical resistance 23
Detachment of device or device component 23
Difficult to position 7
Flaked 6
Delamination 4
Deployment issue 2
Device operates differently than expected 2
Unintended movement 2
No code available 2
Difficult to remove 2
Retraction problem 2
Material separation 2
Collapse 2
Detachment of device component 2
Component falling 1
Slippage of device or device component 1
Material deformation 1
Total Device Problems 1029

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 1 0
Class II 0 0 0 0 0 0 1 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Micro Therapeutics Inc, Dba Ev3 Neurovascular I Nov-09-2016
2 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Oct-14-2015
3 Micro Therapeutics Inc, Dba Ev3 Neurovascular II Aug-23-2013

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