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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
12 15 8 6 16 21 6

Device Problems
Explanted 28
Other (for use when an appropriate device code cannot be identified) 14
Implant, removal of 8
Performance 8
No Information 5
Unknown (for use when the device problem is not known) 4
Gradient increase 4
Fracture 3
Human-Device Interface Issue 3
Paravalvular leak 3
Perivalvular leak 3
Replace 2
No Known Device Problem 2
Migration of device or device component 2
Break 2
Crack 2
Paravalvular leak(s) 2
Strut fracture 1
Leaflet disc escape 1
No code available 1
Leaflet disruption, cause unknown 1
Device remains implanted 1
Device, or device fragments remain in patient 1
Device Issue 1
Leaflet fracture 1
Device operates differently than expected 1
Calcified 1
Material fragmentation 1
Restricted flowrate 1
Valve(s), defective 1
Malfunction 1
Incomplete coaptation 1
Size incorrect for patient 1
Valve(s), failure of 1
Improper or incorrect procedure or method 1
Total Device Problems 113

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0


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