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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 2017
0 0 0 0 0 0 0 0 2 3 0

Device Problems
Fracture 58
Gradient increase 18
No Information 16
Explanted 14
Other (for use when an appropriate device code cannot be identified) 8
Device remains implanted 7
No Known Device Problem 7
Occlusion within device 6
Malposition of device 3
Incomplete coaptation 3
Material perforation 2
Material fragmentation 2
Mineralization 2
Perivalvular leak 2
Balloon burst 2
Migration of device or device component 2
Device operates differently than expected 2
Patient-device incompatibility 1
Material disintegration 1
Human-Device Interface Issue 1
Not Applicable 1
Obstruction within device 1
Deployment issue 1
Increase in pressure 1
Material rupture 1
Rupture, cause unknown 1
Total Device Problems 163

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