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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 2017
0 0 0 0 1 20 48 56 43 61 41

Device Problems
No Known Device Problem 2572
Perivalvular leak 973
Malposition of device 618
Dislodged or dislocated 491
Leak 232
Burst 188
Migration of device or device component 147
No Information 132
Torn material 114
Difficult to remove 99
Fluid leak 88
Incomplete coaptation 71
Gradient increase 70
No code available 61
Calcified 52
Degraded 45
Failure to expand 43
Positioning Issue 42
Unintended movement 37
Material rupture 37
Difficult to position 35
Difficult to advance 35
Material separation 30
Device operates differently than expected 28
Difficult to insert 27
Inflation issue 23
Physical resistance 21
Split 20
Delivery system failure 17
Difficult to deploy 17
Size incorrect for patient 16
Detachment of device component 14
Detachment of device or device component 13
Use of Device Issue 11
Kinked 11
Particulates 10
Bent 10
Entrapment of device or device component 10
Human-Device Interface Issue 10
Material deformation 10
Failure to advance 9
Patient-device incompatibility 8
Slippage of device or device component 8
Deployment issue 6
Folded 6
Failure to deploy 6
Occlusion within device 6
Material integrity issue 6
Foreign material present in device 5
Hole in material 5
Therapy delivered to incorrect body area 5
Device-device incompatibility 5
Inaccurate delivery 5
Retraction problem 4
Failure to separate 4
Crack 4
Air leak 4
Break 4
Fracture 3
Material fragmentation 3
Failure to align 3
Device damaged prior to use 3
Material Distortion 3
Difficult to open or close 2
Not Applicable 2
Sediment, precipitate or deposit in device or device ingredient 2
Obstruction within device 2
Device or device fragments location unknown 2
Buckled material 2
Delamination 1
Device or device component damaged by another device 1
Device packaging compromised 1
Cut in material 1
Component missing 1
Shelf life exceeded 1
Premature deployment 1
User used incorrect product for intended use 1
Material frayed 1
Unintended system motion 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Loose or intermittent connection 1
Blockage within device or device component 1
Computer software issue 1
Failure to conduct 1
Deflation issue 1
Device expiration issue 1
No display or display failure 1
Device handling issue 1
Material Protrusion 1
Material torqued 1
Total Device Problems 6629

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 0 2 0 0
Class II 0 0 0 0 0 0 1 1 0 1 0
Class III 0 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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