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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
No Information 14
Performance 12
Other (for use when an appropriate device code cannot be identified) 11
Replace 10
Calcified 10
No Known Device Problem 10
Mineralization 9
Gradient increase 6
Tears, rips, holes in device, device material 3
Human-Device Interface Issue 3
No code available 2
Device operates differently than expected 2
Occlusion within device 2
Device remains implanted 2
Restricted flowrate 1
Size incorrect for patient 1
Unknown (for use when the device problem is not known) 1
Incomplete coaptation 1
Leaflet disruption, cause unknown 1
Patient-device incompatibility 1
Material Distortion 1
Material integrity issue 1
Therapeutic or diagnostic output failure 1
Total Device Problems 133

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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