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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 54

Device Problems
No Known Device Problem 3012
Perivalvular leak 1143
Malposition of device 691
Dislodged or dislocated 630
Leak 254
Burst 232
No Information 172
Migration of device or device component 171
Torn material 143
Difficult to remove 121
Fluid leak 116
Gradient increase 102
Incomplete coaptation 91
No code available 80
Calcified 68
Degraded 68
Failure to expand 59
Positioning Issue 50
Difficult to position 46
Unintended movement 44
Difficult to advance 43
Material separation 41
Material rupture 38
Difficult to insert 31
Device operates differently than expected 30
Inflation issue 29
Physical resistance 23
Split 21
Size incorrect for patient 21
Difficult to deploy 18
Delivery system failure 17
Detachment of device component 14
Failure to advance 13
Detachment of device or device component 13
Kinked 12
Particulates 11
Bent 11
Use of Device Issue 11
Material deformation 11
Human-Device Interface Issue 10
Inaccurate delivery 10
Entrapment of device or device component 10
Slippage of device or device component 8
Patient-device incompatibility 8
Material integrity issue 8
Deployment issue 6
Folded 6
Failure to deploy 6
Occlusion within device 6
Hole in material 6
Therapy delivered to incorrect body area 5
Foreign material present in device 5
Device-device incompatibility 5
Material Distortion 4
Packaging issue 4
Retraction problem 4
Failure to separate 4
Failure to align 4
Material fragmentation 4
Crack 4
Air leak 4
Break 4
Fracture 3
Delamination 3
Device damaged prior to use 3
Obstruction within device 2
Shelf life exceeded 2
Buckled material 2
Device or device component damaged by another device 2
Device or device fragments location unknown 2
Deflation issue 2
Not Applicable 2
Sediment, precipitate or deposit in device or device ingredient 2
Difficult to open or close 2
Material Protrusion 1
Material torqued 1
Device handling issue 1
Device expiration issue 1
No display or display failure 1
Blockage within device or device component 1
Computer software issue 1
Failure to conduct 1
Material frayed 1
Unintended system motion 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Loose or intermittent connection 1
Device packaging compromised 1
Cut in material 1
Component missing 1
Premature deployment 1
User used incorrect product for intended use 1
Total Device Problems 7881

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 1
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 CryoLife, Inc. II Sep-06-2017
3 Edwards Lifesciences, LLC II Feb-03-2014
4 Edwards Lifesciences, LLC II Apr-17-2013
5 Medtronic Cardiovascular Surgery-the Heart Valve Division II Aug-16-2016
6 Medtronic Cardiovascular Surgery-the Heart Valve Division I Aug-05-2015

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