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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 39
Explanted 28
No Known Device Problem 16
Gradient increase 14
Performance 12
Calcified 12
Other (for use when an appropriate device code cannot be identified) 11
Replace 10
Mineralization 9
Occlusion within device 4
Tears, rips, holes in device, device material 3
Incomplete coaptation 3
Human-Device Interface Issue 3
No code available 3
Device operates differently than expected 2
Size incorrect for patient 2
Device remains implanted 2
Restricted flowrate 2
Leak 1
Leaflet disruption, cause unknown 1
Patient-device incompatibility 1
Biocompatibility issue 1
Therapeutic or diagnostic output failure 1
Material Distortion 1
Material integrity issue 1
Unknown (for use when the device problem is not known) 1
Total Device Problems 183

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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