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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 2014 2015 2016 2017
5 9 11 6 13 9 5 7 5 17 12

Device Problems
Migration of device or device component 53
Explanted 32
No Information 24
Unintended movement 16
No Known Device Problem 14
Difficult to remove 14
Replace 13
Device, removal of (non-implant) 11
Malposition of device 10
Size incorrect for patient 10
Device operates differently than expected 9
Material deformation 9
Device remains implanted 7
Sticking 6
Leak 6
Dislodged 6
Material erosion 6
Retraction problem 5
Dislodged or dislocated 5
Positioning Issue 5
Implant, removal of 5
Detachment of device component 4
Break 3
Entrapment of device or device component 3
Failure to advance 3
Deployment issue 2
Extrusion 2
No code available 2
Failure to deploy 2
Fracture 2
Material separation 2
Difficult to position 2
Slippage of device or device component 2
Unstable 2
Use of Device Issue 2
Other (for use when an appropriate device code cannot be identified) 1
Unknown (for use when the device problem is not known) 1
Stretched 1
Tip breakage 1
Premature deployment 1
Device, or device fragments remain in patient 1
Difficult to insert 1
Kinked 1
Foreign material 1
Loose 1
Mechanical issue 1
Mislocation 1
Collapse 1
Component(s), worn 1
Material integrity issue 1
Physical resistance 1
Obstruction within device 1
Device or device component damaged by another device 1
Buckled material 1
Total Device Problems 318

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015

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