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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 1

Device Problems
Unknown (for use when the device problem is not known) 1550
Explanted 288
Paravalvular leak 215
No Known Device Problem 180
Deterioration of prosthesis 179
No Information 172
Other (for use when an appropriate device code cannot be identified) 142
Gradient increase 124
Performance 94
Perivalvular leak 92
Tears, rips, holes in device, device material 91
Calcified 77
Replace 76
Incomplete coaptation 55
Mineralization 45
Device operates differently than expected 31
Structural problem 28
Malposition of device 27
Torn material 24
Leaflet disruption, cause unknown 23
No code available 19
Leak 19
Size incorrect for patient 18
Leaflet disruption due to suture abrasion 18
Human-Device Interface Issue 18
Material perforation 16
Patient-device incompatibility 14
Device remains implanted 11
Paravalvular leak(s) 10
Material rupture 10
Hole in material 9
Material rigid or stiff 8
Detachment of device component 8
Material deformation 7
Improper or incorrect procedure or method 7
Use of Device Issue 7
Degraded 6
Dislodged or dislocated 6
Occlusion within device 6
Fibrosis 6
Fracture 5
Migration of device or device component 4
Obstruction within device 4
Material separation 4
Device Issue 4
Fluid leak 4
Implant, removal of 3
Material Distortion 3
Restricted flowrate 3
Deployment issue 3
Therapeutic or diagnostic output failure 2
Not Applicable 2
Material puncture 2
Valve(s), defective 2
Material frayed 2
Bent 2
Failure to Adhere or Bond 2
Material integrity issue 2
Positioning Issue 2
Rupture due to damage from surgical instrument 2
End of prosthetic life 2
Detachment of device or device component 2
Crack 2
Bacterial contamination of device 2
Break 2
Cut in material 2
Unsealed device packaging 2
Unintended movement 2
Foreign material present in device 2
Valve(s), failure of 2
Aspiration issue 1
Reflux within device 1
Biological environmental factor 1
Repair 1
Material fragmentation 1
Out-of-box failure 1
Device packaging compromised 1
Folded 1
Naturally worn 1
Defective item 1
Split 1
Shelf life exceeded 1
Difficult to position 1
Component(s), broken 1
Fungus in device environment 1
Entrapment of device or device component 1
Suture line disruption 1
Loose or intermittent connection 1
Kinked 1
Defective component 1
Device inoperable 1
Burst 1
Device remains activated 1
Increase in pressure 1
Coagulation in device or device ingredient 1
Invalid sensing 1
Difficult to deploy 1
Air eliminator, defective 1
Particulates 1
Device abrasion from instrument or another object 1
Total Device Problems 3843

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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