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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
0 0 0 0 3 1 4 3 1 1

Device Problems
Failure to expand 221
No Known Device Problem 110
Failure to deploy 24
Break 22
Migration of device or device component 19
Detachment of device or device component 10
Physical resistance 4
Flaked 3
Detachment of device component 2
Retraction problem 2
Material separation 2
Deployment issue 2
Device operates differently than expected 2
Material deformation 1
No code available 1
Slippage of device or device component 1
Difficult to remove 1
Component falling 1
Total Device Problems 428

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

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