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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulmonary valve prosthesis percutaneously delivered
Definition These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPV
Device Class Humanitarian Device Exemption

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 0 0 2 3

Device Problems
Fracture 48
Gradient increase 15
Explanted 14
No Information 12
Other (for use when an appropriate device code cannot be identified) 8
Device remains implanted 7
No Known Device Problem 7
Occlusion within device 4
Malposition of device 3
Migration of device or device component 2
Mineralization 2
Balloon burst 2
Incomplete coaptation 2
Not Applicable 1
Material disintegration 1
Material fragmentation 1
Perivalvular leak 1
Increase in pressure 1
Deployment issue 1
Device operates differently than expected 1
Human-Device Interface Issue 1
Material rupture 1
Rupture, cause unknown 1
Material perforation 1
Total Device Problems 137

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