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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 102
No Known Device Problem 78
Explanted 28
No code available 22
Perivalvular leak 21
Gradient increase 19
Incomplete coaptation 19
Mechanical jam 17
Size incorrect for patient 15
Other (for use when an appropriate device code cannot be identified) 14
Interference 12
Fracture 10
Device operates differently than expected 10
Implant, removal of 8
Obstruction within device 8
Performance 8
Device remains implanted 7
Break 7
Leak 6
Material fragmentation 5
Improper or incorrect procedure or method 5
Paravalvular leak(s) 4
Contamination during use 4
Unknown (for use when the device problem is not known) 4
Paravalvular leak 3
Patient-device incompatibility 3
Human-Device Interface Issue 3
Difficult to open or close 3
Crack 3
Calcified 2
Detachment of device component 2
Mechanical issue 2
Migration of device or device component 2
Blockage within device or device component 2
Replace 2
Material separation 2
Shelf life exceeded 2
Dislodged or dislocated 2
Leaflet fracture 2
Device handling issue 2
Structural problem 2
Detachment of device or device component 1
Impedance issue 1
Improper flow or infusion 1
Material integrity issue 1
Leaflet disruption, cause unknown 1
Malposition of device 1
Valve(s), defective 1
Device Issue 1
Malfunction 1
Noise, Audible 1
Strut fracture 1
Unraveled material 1
Use of Device Issue 1
Valve(s), failure of 1
Valve(s), sticking 1
Device, or device fragments remain in patient 1
Difficult to position 1
Device Difficult to Setup or Prepare 1
Reflux within device 1
Occlusion within device 1
Leaflet disc escape 1
Restricted flowrate 1
Degraded 1
Material disintegration 1
Entrapment of device or device component 1
Total Device Problems 497

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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