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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 43

Device Problems
No Known Device Problem 1344
Perivalvular leak 519
Malposition of device 356
Dislodged or dislocated 226
Leak 168
Migration of device or device component 83
Burst 83
No Information 62
Torn material 56
No code available 41
Difficult to remove 37
Incomplete coaptation 31
Device operates differently than expected 25
Gradient increase 25
Degraded 24
Material rupture 19
Unintended movement 18
Failure to expand 17
Inflation issue 17
Difficult to insert 17
Difficult to advance 16
Delivery system failure 15
Fluid leak 15
Positioning Issue 14
Material separation 14
Split 13
Physical resistance 12
Difficult to deploy 12
Calcified 12
Difficult to position 11
Detachment of device component 10
Use of Device Issue 9
Patient-device incompatibility 8
Slippage of device or device component 7
Detachment of device or device component 7
Human-Device Interface Issue 6
Bent 6
Entrapment of device or device component 6
Failure to deploy 5
Particulates 5
Failure to separate 4
Failure to advance 4
Deployment issue 4
Air leak 4
Hole in material 4
Kinked 4
Retraction problem 4
Occlusion within device 4
Device-device incompatibility 4
Fracture 3
Material fragmentation 3
Break 3
Material deformation 3
Size incorrect for patient 3
Inaccurate delivery 2
Obstruction within device 2
Folded 2
Foreign material present in device 2
Crack 2
Deflation issue 1
Computer software issue 1
Material frayed 1
No display or display failure 1
Unintended system motion 1
Nonstandard device or device component 1
Delivered as unsterile product 1
Premature deployment 1
Loose or intermittent connection 1
Difficult to open or close 1
Delamination 1
Device or device component damaged by another device 1
Device or device fragments location unknown 1
Device damaged prior to use 1
Shelf life exceeded 1
Not Applicable 1
Total Device Problems 3448

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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