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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 2014 2015 2016
0 0 0 0 1 20 48 56 43 12

Device Problems
No Known Device Problem 1073
Perivalvular leak 375
Malposition of device 279
Dislodged or dislocated 144
Leak 116
Burst 63
Migration of device or device component 58
No Information 47
Torn material 41
No code available 31
Difficult to remove 29
Incomplete coaptation 26
Device operates differently than expected 21
Gradient increase 15
Unintended movement 15
Material rupture 14
Delivery system failure 13
Inflation issue 13
Degraded 12
Failure to expand 12
Difficult to advance 12
Difficult to insert 11
Detachment of device component 10
Material separation 10
Positioning Issue 9
Split 9
Physical resistance 9
Patient-device incompatibility 8
Difficult to deploy 8
Fluid leak 8
Difficult to position 8
Use of Device Issue 7
Bent 6
Slippage of device or device component 6
Detachment of device or device component 6
Entrapment of device or device component 5
Human-Device Interface Issue 5
Calcified 4
Retraction problem 4
Deployment issue 4
Failure to separate 4
Air leak 4
Failure to deploy 4
Device-device incompatibility 4
Size incorrect for patient 3
Material fragmentation 3
Kinked 3
Break 3
Particulates 3
Occlusion within device 3
Fracture 3
Failure to advance 3
Obstruction within device 2
Crack 2
Hole in material 2
Folded 2
Foreign material present in device 2
Material deformation 2
Nonstandard device or device component 1
Inaccurate delivery 1
Premature deployment 1
Device or device fragments location unknown 1
Loose or intermittent connection 1
Computer software issue 1
Device damaged prior to use 1
Delamination 1
No display or display failure 1
Deflation issue 1
Difficult to open or close 1
Unintended system motion 1
Material frayed 1
Total Device Problems 2611

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 2 0
Class II 0 0 0 0 0 0 1 1 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-13-2015
2 Edwards Lifesciences, LLC II Feb-03-2014
3 Edwards Lifesciences, LLC II Apr-17-2013
4 Medtronic Cardiovascular Surgery-the Heart Valve Division I Aug-05-2015

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