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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 3 (513(f)(1))

Device Problems
Fracture 30
Explanted 14
Other (for use when an appropriate device code cannot be identified) 8
Device remains implanted 7
Gradient increase 3
Mineralization 2
Balloon burst 2
Rupture, cause unknown 1
Material perforation 1
Human-Device Interface Issue 1
Total Device Problems 69

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