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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
8 7 15 17 25 18 31 27 14 7

Device Problems
Unknown (for use when the device problem is not known) 1550
Explanted 288
Paravalvular leak 215
Deterioration of prosthesis 179
Other (for use when an appropriate device code cannot be identified) 142
No Known Device Problem 102
Performance 94
Tears, rips, holes in device, device material 91
No Information 78
Gradient increase 77
Replace 76
Calcified 73
Perivalvular leak 72
Mineralization 45
Incomplete coaptation 42
Malposition of device 26
Structural problem 23
Leaflet disruption, cause unknown 23
Torn material 21
Leak 18
Leaflet disruption due to suture abrasion 18
Human-Device Interface Issue 18
No code available 16
Device operates differently than expected 14
Material perforation 14
Patient-device incompatibility 13
Device remains implanted 11
Paravalvular leak(s) 10
Hole in material 8
Detachment of device component 8
Material rigid or stiff 7
Improper or incorrect procedure or method 7
Use of Device Issue 7
Fibrosis 6
Size incorrect for patient 6
Fracture 5
Dislodged or dislocated 5
Occlusion within device 5
Migration of device or device component 4
Material deformation 4
Device Issue 4
Fluid leak 4
Implant, removal of 3
Material separation 3
Deployment issue 3
Degraded 3
Obstruction within device 3
Not Applicable 2
Therapeutic or diagnostic output failure 2
Material frayed 2
Valve(s), defective 2
Material integrity issue 2
Failure to Adhere or Bond 2
Unsealed device packaging 2
Unintended movement 2
Foreign material present in device 2
Valve(s), failure of 2
Cut in material 2
End of prosthetic life 2
Detachment of device or device component 2
Crack 2
Bacterial contamination of device 2
Rupture due to damage from surgical instrument 2
Suture line disruption 1
Fungus in device environment 1
Material Distortion 1
Positioning Issue 1
Entrapment of device or device component 1
Restricted flowrate 1
Kinked 1
Material rupture 1
Difficult to position 1
Break 1
Component(s), broken 1
Naturally worn 1
Defective item 1
Aspiration issue 1
Material fragmentation 1
Out-of-box failure 1
Repair 1
Device inoperable 1
Defective component 1
Bent 1
Burst 1
Air eliminator, defective 1
Invalid sensing 1
Increase in pressure 1
Device remains activated 1
Coagulation in device or device ingredient 1
Difficult to deploy 1
Component missing 1
Material invagination 1
Device abrasion from instrument or another object 1
Particulates 1
Premature explantation 1
Material puncture 1
Total Device Problems 3509

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

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