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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 2

Device Problems
No Known Device Problem 2002
Perivalvular leak 759
Malposition of device 487
Dislodged or dislocated 346
Leak 206
Burst 132
Migration of device or device component 113
No Information 93
Torn material 85
Difficult to remove 67
Fluid leak 56
Incomplete coaptation 47
No code available 46
Gradient increase 42
Degraded 32
Calcified 32
Failure to expand 30
Positioning Issue 30
Device operates differently than expected 27
Material rupture 26
Unintended movement 26
Difficult to advance 22
Material separation 21
Inflation issue 21
Difficult to insert 21
Difficult to position 21
Physical resistance 19
Split 18
Delivery system failure 16
Difficult to deploy 15
Detachment of device component 12
Detachment of device or device component 12
Use of Device Issue 11
Entrapment of device or device component 10
Size incorrect for patient 9
Material deformation 9
Human-Device Interface Issue 8
Particulates 8
Patient-device incompatibility 8
Bent 8
Kinked 7
Slippage of device or device component 7
Failure to advance 6
Occlusion within device 6
Hole in material 5
Failure to deploy 5
Foreign material present in device 5
Therapy delivered to incorrect body area 5
Device-device incompatibility 5
Retraction problem 4
Inaccurate delivery 4
Failure to separate 4
Deployment issue 4
Break 4
Crack 4
Air leak 4
Fracture 3
Material fragmentation 3
Folded 3
Material Distortion 3
Obstruction within device 2
Device damaged prior to use 2
Component missing 1
Failure to align 1
Shelf life exceeded 1
Device or device fragments location unknown 1
Delamination 1
Difficult to open or close 1
Device or device component damaged by another device 1
Device packaging compromised 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 integrity issue 1
Material torqued 1
Not Applicable 1
Device handling issue 1
Total Device Problems 5070

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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