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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 55

Device Problems
No Known Device Problem 1616
Perivalvular leak 636
Malposition of device 412
Dislodged or dislocated 277
Leak 195
Burst 104
Migration of device or device component 100
No Information 76
Torn material 68
Difficult to remove 52
No code available 42
Incomplete coaptation 40
Fluid leak 36
Gradient increase 35
Degraded 30
Device operates differently than expected 27
Material rupture 26
Positioning Issue 23
Failure to expand 22
Calcified 21
Difficult to insert 21
Unintended movement 20
Material separation 19
Difficult to advance 19
Inflation issue 18
Split 17
Difficult to position 17
Delivery system failure 16
Physical resistance 15
Difficult to deploy 12
Detachment of device component 11
Use of Device Issue 9
Patient-device incompatibility 8
Detachment of device or device component 8
Bent 8
Entrapment of device or device component 7
Slippage of device or device component 7
Human-Device Interface Issue 7
Size incorrect for patient 6
Particulates 6
Kinked 6
Hole in material 5
Occlusion within device 5
Failure to deploy 5
Device-device incompatibility 5
Foreign material present in device 5
Deployment issue 4
Retraction problem 4
Failure to separate 4
Failure to advance 4
Break 4
Crack 4
Air leak 4
Material deformation 4
Fracture 3
Material fragmentation 3
Inaccurate delivery 3
Obstruction within device 2
Device damaged prior to use 2
Folded 2
Device or device fragments location unknown 1
Delamination 1
Difficult to open or close 1
Device or device component damaged by another device 1
Shelf life exceeded 1
Material frayed 1
No display or display failure 1
Deflation issue 1
Computer software issue 1
Loose or intermittent connection 1
Unintended system motion 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Premature deployment 1
User used incorrect product for intended use 1
Material Distortion 1
Not Applicable 1
Total Device Problems 4184

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 1
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 II Aug-16-2016
5 Medtronic Cardiovascular Surgery-the Heart Valve Division I Aug-05-2015

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