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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulmonic valved conduit
Product CodeMWH
Device Class Humanitarian Device Exemption

Device Problems
No Information 68
No Known Device Problem 30
Explanted 28
Gradient increase 25
Calcified 16
Performance 12
Other (for use when an appropriate device code cannot be identified) 11
Replace 10
Mineralization 9
Device operates differently than expected 8
No code available 4
Occlusion within device 4
Size incorrect for patient 3
Tears, rips, holes in device, device material 3
Human-Device Interface Issue 3
Incomplete coaptation 3
Material integrity issue 2
Device remains implanted 2
Restricted flowrate 2
Leak 1
Increase in pressure 1
Material separation 1
Unknown (for use when the device problem is not known) 1
Obstruction within device 1
Leaflet disruption, cause unknown 1
Patient-device incompatibility 1
Biocompatibility issue 1
Material Distortion 1
Therapeutic or diagnostic output failure 1
Total Device Problems 253

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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