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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcatheter septal occluder
Definition Approved PMA: P000039
Product CodeMLV
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
5 9 11 6 13 9 0

Device Problems
Migration of device or device component 42
Explanted 32
No Information 17
Replace 13
Device, removal of (non-implant) 11
Difficult to remove 11
Malposition of device 10
Size incorrect for patient 9
Device remains implanted 7
Dislodged 6
Sticking 5
Implant, removal of 5
Material erosion 4
Retraction problem 3
Material separation 2
Slippage of device or device component 2
Unstable 2
Use of Device Issue 2
Failure to advance 2
Difficult to position 2
Dislodged or dislocated 2
Material deformation 2
Material integrity issue 1
Positioning Issue 1
No code available 1
Premature deployment 1
Mislocation 1
Device, or device fragments remain in patient 1
Entrapment of device or device component 1
Collapse 1
Detachment of device component 1
Component(s), worn 1
Foreign material 1
Fracture 1
Difficult to insert 1
Kinked 1
Loose 1
Mechanical issue 1
Physical resistance 1
Stretched 1
Tip breakage 1
Buckled material 1
Deployment issue 1
Device or device component damaged by another device 1
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 215

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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