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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heart-valve, non-allograft tissue
Product CodeLWR
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
8 7 15 17 25 18 31 27 14 27 7

Device Problems
Unknown (for use when the device problem is not known) 1550
Explanted 288
Paravalvular leak 215
No Information 191
No Known Device Problem 189
Deterioration of prosthesis 179
Other (for use when an appropriate device code cannot be identified) 142
Gradient increase 128
Perivalvular leak 95
Performance 94
Tears, rips, holes in device, device material 91
Calcified 81
Replace 76
Incomplete coaptation 58
Mineralization 45
Device operates differently than expected 37
Structural problem 28
Malposition of device 27
Torn material 24
Leaflet disruption, cause unknown 23
Size incorrect for patient 20
Leak 19
No code available 19
Human-Device Interface Issue 18
Leaflet disruption due to suture abrasion 18
Material perforation 16
Patient-device incompatibility 14
Material rigid or stiff 11
Material rupture 11
Device remains implanted 11
Hole in material 10
Paravalvular leak(s) 10
Detachment of device component 8
Improper or incorrect procedure or method 7
Use of Device Issue 7
Material deformation 7
Dislodged or dislocated 7
Fibrosis 6
Degraded 6
Occlusion within device 6
Fracture 5
Fluid leak 4
Migration of device or device component 4
Material separation 4
Device Issue 4
Obstruction within device 4
Implant, removal of 3
Restricted flowrate 3
Break 3
Deployment issue 3
Material Distortion 3
Material integrity issue 2
Foreign material present in device 2
Unintended movement 2
Not Applicable 2
Positioning Issue 2
Therapeutic or diagnostic output failure 2
Detachment of device or device component 2
Failure to Adhere or Bond 2
Bent 2
Crack 2
Material frayed 2
Kinked 2
Unsealed device packaging 2
Material puncture 2
Valve(s), defective 2
Cut in material 2
End of prosthetic life 2
Bacterial contamination of device 2
Rupture due to damage from surgical instrument 2
Valve(s), failure of 2
Suture line disruption 1
Device inoperable 1
Shelf life exceeded 1
Repair 1
Component missing 1
Out-of-box failure 1
Fungus in device environment 1
Defective component 1
Invalid sensing 1
Air eliminator, defective 1
Reflux within device 1
Device remains activated 1
Particulates 1
Difficult to position 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
Material invagination 1
Loose or intermittent connection 1
Device abrasion from instrument or another object 1
Material fragmentation 1
Difficult to deploy 1
Entrapment of device or device component 1
Coagulation in device or device ingredient 1
Component(s), broken 1
Burst 1
Folded 1
Aspiration issue 1
Biological environmental factor 1
Total Device Problems 3901

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

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Cardiovascular Surgery-the Heart Valve Division II Feb-03-2014
2 Sorin Group USA, Inc. II Dec-07-2016

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