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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 90
No Known Device Problem 71
Explanted 28
No code available 21
Perivalvular leak 20
Gradient increase 18
Mechanical jam 17
Incomplete coaptation 16
Size incorrect for patient 14
Other (for use when an appropriate device code cannot be identified) 14
Interference 12
Device operates differently than expected 9
Implant, removal of 8
Fracture 8
Performance 8
Device remains implanted 7
Break 7
Obstruction within device 7
Material fragmentation 5
Leak 4
Contamination during use 4
Paravalvular leak(s) 4
Improper or incorrect procedure or method 4
Unknown (for use when the device problem is not known) 4
Paravalvular leak 3
Human-Device Interface Issue 3
Difficult to open or close 2
Patient-device incompatibility 2
Structural problem 2
Leaflet fracture 2
Device handling issue 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
Noise, Audible 1
Device Issue 1
Malfunction 1
Leaflet disruption, cause unknown 1
Malposition of device 1
Detachment of device or device component 1
Impedance issue 1
Improper flow or infusion 1
Material integrity issue 1
Total Device Problems 458

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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