• 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 1

Device Problems
Failure to expand 197
No Known Device Problem 77
Failure to deploy 21
Break 19
Migration of device or device component 15
Detachment of device or device component 10
Flaked 3
Detachment of device component 2
Retraction problem 2
Material separation 2
Device operates differently than expected 2
Physical resistance 2
Deployment issue 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 359

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

-
-