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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heart-valve, mechanical
Product CodeLWQ
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
12 15 8 6 16 21 17 11 14 3

Device Problems
Explanted 28
Other (for use when an appropriate device code cannot be identified) 14
No Information 14
Gradient increase 12
Interference 12
No Known Device Problem 11
Mechanical jam 8
Implant, removal of 8
Performance 8
Device remains implanted 7
Incomplete coaptation 7
Fracture 6
Size incorrect for patient 5
Device operates differently than expected 5
No code available 5
Unknown (for use when the device problem is not known) 4
Paravalvular leak(s) 4
Perivalvular leak 4
Material fragmentation 3
Break 3
Human-Device Interface Issue 3
Obstruction within device 3
Paravalvular leak 3
Structural problem 2
Leaflet fracture 2
Crack 2
Leak 2
Mechanical issue 2
Migration of device or device component 2
Improper or incorrect procedure or method 2
Replace 2
Material separation 1
Valve(s), defective 1
Device Issue 1
Malfunction 1
Strut fracture 1
Unraveled material 1
Valve(s), failure of 1
Valve(s), sticking 1
Device, or device fragments remain in patient 1
Leaflet disc escape 1
Occlusion within device 1
Device Difficult to Setup or Prepare 1
Reflux within device 1
Entrapment of device or device component 1
Calcified 1
Restricted flowrate 1
Impedance issue 1
Material integrity issue 1
Device handling issue 1
Noise, Audible 1
Difficult to open or close 1
Leaflet disruption, cause unknown 1
Patient-device incompatibility 1
Total Device Problems 216

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 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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