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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 311
No Known Device Problem 193
Failure to deploy 43
Break 36
Migration of device or device component 27
Detachment of device or device component 18
Physical resistance 7
Flaked 6
Difficult to position 3
Delamination 3
Deployment issue 2
Retraction problem 2
Material separation 2
Device operates differently than expected 2
Collapse 2
Detachment of device component 2
Component falling 1
Difficult to remove 1
Material deformation 1
No code available 1
Slippage of device or device component 1
Total Device Problems 664

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