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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 7

Device Problems
Explanted 28
No Information 15
No Known Device Problem 14
Other (for use when an appropriate device code cannot be identified) 14
Gradient increase 12
Interference 12
Size incorrect for patient 8
Implant, removal of 8
Performance 8
Perivalvular leak 8
Mechanical jam 8
Incomplete coaptation 8
Device remains implanted 7
Fracture 6
Device operates differently than expected 6
No code available 5
Break 5
Material fragmentation 4
Unknown (for use when the device problem is not known) 4
Paravalvular leak(s) 4
Improper or incorrect procedure or method 3
Human-Device Interface Issue 3
Obstruction within device 3
Paravalvular leak 3
Structural problem 2
Difficult to open or close 2
Leaflet fracture 2
Replace 2
Crack 2
Leak 2
Mechanical issue 2
Migration of device or device component 2
Occlusion within device 1
Device Difficult to Setup or Prepare 1
Reflux within device 1
Degraded 1
Entrapment of device or device component 1
Calcified 1
Restricted flowrate 1
Material separation 1
Shelf life exceeded 1
Valve(s), defective 1
Device Issue 1
Malfunction 1
Device, or device fragments remain in patient 1
Leaflet disc escape 1
Strut fracture 1
Unraveled material 1
Use of Device Issue 1
Valve(s), failure of 1
Valve(s), sticking 1
Impedance issue 1
Material integrity issue 1
Device handling issue 1
Noise, Audible 1
Leaflet disruption, cause unknown 1
Patient-device incompatibility 1
Total Device Problems 237

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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