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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aortic valve, prosthesis, percutaneously delivered
Definition To replace a patient's aortic 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 CodeNPT
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013
0 0 0 0 1 20 11

Device Problems
No Known Device Problem 8
Malposition of device 3
Dislodged or dislocated 2
Leak 1
Incomplete coaptation 1
Positioning Issue 1
Total Device Problems 16

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 1
Class III 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II Apr-17-2013

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