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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 42

Device Problems
Unknown (for use when the device problem is not known) 1550
No Information 582
No Known Device Problem 314
Explanted 288
Gradient increase 248
Paravalvular leak 215
Perivalvular leak 182
Deterioration of prosthesis 179
Other (for use when an appropriate device code cannot be identified) 142
Calcified 108
Incomplete coaptation 100
Performance 94
Tears, rips, holes in device, device material 91
Torn material 77
Replace 76
Size incorrect for patient 63
Device operates differently than expected 58
Leak 46
Mineralization 45
Material deformation 39
Obstruction within device 37
Structural problem 34
Malposition of device 34
Patient-device incompatibility 32
No code available 32
Material rigid or stiff 32
Material rupture 24
Leaflet disruption, cause unknown 23
Material perforation 19
Leaflet disruption due to suture abrasion 18
Human-Device Interface Issue 18
Dislodged or dislocated 18
Hole in material 15
Degraded 11
Device remains implanted 11
Paravalvular leak(s) 10
Kinked 10
Folded 10
Occlusion within device 9
Detachment of device component 9
Improper or incorrect procedure or method 9
Bacterial contamination of device 9
Use of Device Issue 8
Fluid leak 6
Fracture 6
Migration of device or device component 6
Fibrosis 6
Material separation 5
Cut in material 4
Difficult to fold or unfold 4
Device Issue 4
Deployment issue 4
Material Distortion 4
Material integrity issue 3
Naturally worn 3
Restricted flowrate 3
Bent 3
Break 3
Implant, removal of 3
Valve(s), defective 2
Valve(s), failure of 2
Rupture due to damage from surgical instrument 2
Crack 2
Failure to Adhere or Bond 2
Material frayed 2
Unsealed device packaging 2
Material invagination 2
Material puncture 2
Positioning Issue 2
Therapeutic or diagnostic output failure 2
Detachment of device or device component 2
Foreign material present in device 2
Difficult to open or close 2
End of prosthetic life 2
Unintended movement 2
Not Applicable 2
Device handling issue 1
Split 1
Defective item 1
Aspiration issue 1
Biological environmental factor 1
Buckled material 1
Capturing issue 1
Delivery system failure 1
Device packaging compromised 1
Improper flow or infusion 1
Product quality issue 1
Reflux within device 1
Device remains activated 1
Difficult to position 1
Premature explantation 1
Device Difficult to Setup or Prepare 1
Increase in pressure 1
User used incorrect product for intended use 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
Burst 1
Total Device Problems 5054

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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