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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 51

Device Problems
No Known Device Problem 1432
Perivalvular leak 563
Malposition of device 381
Dislodged or dislocated 248
Leak 177
Burst 90
Migration of device or device component 89
No Information 68
Torn material 61
No code available 42
Difficult to remove 42
Incomplete coaptation 33
Gradient increase 28
Device operates differently than expected 26
Degraded 25
Material rupture 22
Fluid leak 20
Failure to expand 20
Unintended movement 19
Difficult to insert 19
Inflation issue 17
Calcified 17
Difficult to advance 17
Positioning Issue 17
Delivery system failure 16
Split 16
Physical resistance 15
Material separation 15
Difficult to deploy 12
Difficult to position 12
Detachment of device component 10
Use of Device Issue 9
Patient-device incompatibility 8
Detachment of device or device component 7
Human-Device Interface Issue 7
Slippage of device or device component 7
Bent 7
Entrapment of device or device component 6
Hole in material 5
Particulates 5
Occlusion within device 5
Failure to deploy 5
Size incorrect for patient 5
Failure to advance 4
Failure to separate 4
Retraction problem 4
Foreign material present in device 4
Device-device incompatibility 4
Deployment issue 4
Break 4
Air leak 4
Kinked 4
Crack 3
Fracture 3
Material fragmentation 3
Material deformation 3
Folded 2
Device damaged prior to use 2
Inaccurate delivery 2
Obstruction within device 2
Shelf life exceeded 1
Device or device fragments location unknown 1
Delamination 1
Device or device component damaged by another device 1
Difficult to open or close 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
Not Applicable 1
Total Device Problems 3716

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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