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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 411
No Known Device Problem 302
Failure to deploy 50
Break 41
Migration of device or device component 38
Detachment of device or device component 23
Physical resistance 19
Difficult to position 6
Flaked 6
Delamination 3
Deployment issue 2
Retraction problem 2
Material separation 2
Device operates differently than expected 2
Unintended movement 2
Collapse 2
Detachment of device component 2
Component falling 1
Difficult to remove 1
No code available 1
Material deformation 1
Slippage of device or device component 1
Total Device Problems 918

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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