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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
Explanted 28
Performance 12
No Information 12
Other (for use when an appropriate device code cannot be identified) 11
Replace 10
Mineralization 9
Calcified 9
No Known Device Problem 8
Gradient increase 4
Tears, rips, holes in device, device material 3
Human-Device Interface Issue 3
Device operates differently than expected 2
Device remains implanted 2
Size incorrect for patient 1
Incomplete coaptation 1
Material Distortion 1
Patient-device incompatibility 1
Material integrity issue 1
Unknown (for use when the device problem is not known) 1
Leaflet disruption, cause unknown 1
Therapeutic or diagnostic output failure 1
No code available 1
Occlusion within device 1
Total Device Problems 123

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0


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