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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 2017
12 15 8 6 16 21 17 11 14 13 3

Device Problems
No Information 64
No Known Device Problem 52
Explanted 28
No code available 19
Perivalvular leak 16
Gradient increase 15
Other (for use when an appropriate device code cannot be identified) 14
Mechanical jam 13
Interference 12
Size incorrect for patient 11
Incomplete coaptation 10
Implant, removal of 8
Performance 8
Device remains implanted 7
Fracture 7
Device operates differently than expected 7
Break 6
Material fragmentation 5
Obstruction within device 5
Leak 4
Contamination during use 4
Paravalvular leak(s) 4
Unknown (for use when the device problem is not known) 4
Improper or incorrect procedure or method 3
Paravalvular leak 3
Human-Device Interface Issue 3
Difficult to open or close 2
Leaflet fracture 2
Structural problem 2
Blockage within device or device component 2
Replace 2
Material separation 2
Shelf life exceeded 2
Crack 2
Calcified 2
Detachment of device component 2
Mechanical issue 2
Migration of device or device component 2
Occlusion within device 1
Leaflet disc escape 1
Restricted flowrate 1
Degraded 1
Material disintegration 1
Entrapment of device or device component 1
Device, or device fragments remain in patient 1
Device Difficult to Setup or Prepare 1
Reflux within device 1
Valve(s), defective 1
Strut fracture 1
Unraveled material 1
Use of Device Issue 1
Valve(s), failure of 1
Valve(s), sticking 1
Device Issue 1
Malfunction 1
Leaflet disruption, cause unknown 1
Malposition of device 1
Patient-device incompatibility 1
Detachment of device or device component 1
Impedance issue 1
Improper flow or infusion 1
Material integrity issue 1
Device handling issue 1
Noise, Audible 1
Total Device Problems 382

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


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