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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 20

Device Problems
Unknown (for use when the device problem is not known) 1550
Explanted 288
No Information 285
No Known Device Problem 237
Paravalvular leak 215
Deterioration of prosthesis 179
Gradient increase 169
Other (for use when an appropriate device code cannot be identified) 142
Perivalvular leak 138
Performance 94
Tears, rips, holes in device, device material 91
Calcified 88
Incomplete coaptation 77
Replace 76
Device operates differently than expected 49
Mineralization 45
Torn material 39
Size incorrect for patient 35
Malposition of device 31
Structural problem 30
Leak 26
Leaflet disruption, cause unknown 23
Material deformation 22
Material rigid or stiff 22
No code available 21
Patient-device incompatibility 19
Leaflet disruption due to suture abrasion 18
Human-Device Interface Issue 18
Material perforation 16
Hole in material 13
Device remains implanted 11
Material rupture 11
Dislodged or dislocated 11
Obstruction within device 10
Paravalvular leak(s) 10
Detachment of device component 9
Improper or incorrect procedure or method 9
Degraded 8
Kinked 8
Occlusion within device 7
Use of Device Issue 7
Fluid leak 6
Fibrosis 6
Folded 5
Fracture 5
Migration of device or device component 5
Bacterial contamination of device 5
Device Issue 4
Material separation 4
Deployment issue 4
Material Distortion 4
Material integrity issue 3
Implant, removal of 3
Restricted flowrate 3
Bent 3
Break 3
Crack 2
Material invagination 2
Failure to Adhere or Bond 2
Material frayed 2
Unsealed device packaging 2
Material puncture 2
Cut in material 2
End of prosthetic life 2
Valve(s), defective 2
Rupture due to damage from surgical instrument 2
Valve(s), failure of 2
Foreign material present in device 2
Difficult to open or close 2
Unintended movement 2
Not Applicable 2
Positioning Issue 2
Therapeutic or diagnostic output failure 2
Detachment of device or device component 2
Device packaging compromised 1
Aspiration issue 1
Biological environmental factor 1
Buckled material 1
Capturing issue 1
Delivery system failure 1
Defective item 1
Split 1
Device handling issue 1
Naturally worn 1
Device inoperable 1
Defective component 1
Invalid sensing 1
Shelf life exceeded 1
Stretched 1
Suture line disruption 1
Air eliminator, defective 1
Component missing 1
Out-of-box failure 1
Fungus in device environment 1
Reflux within device 1
Device remains activated 1
Repair 1
Difficult to position 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Total Device Problems 4282

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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