• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 23

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 138
No Information 126
Gradient increase 98
Performance 94
Tears, rips, holes in device, device material 91
Perivalvular leak 83
Replace 76
Calcified 74
Incomplete coaptation 50
Mineralization 45
Structural problem 26
Malposition of device 26
Leaflet disruption, cause unknown 23
Torn material 23
Device operates differently than expected 20
Leaflet disruption due to suture abrasion 18
Human-Device Interface Issue 18
Leak 18
No code available 16
Material perforation 15
Patient-device incompatibility 13
Device remains implanted 11
Size incorrect for patient 11
Paravalvular leak(s) 10
Hole in material 8
Detachment of device component 8
Material rigid or stiff 8
Material rupture 7
Improper or incorrect procedure or method 7
Use of Device Issue 7
Fibrosis 6
Dislodged or dislocated 6
Material deformation 6
Degraded 5
Fracture 5
Occlusion within device 5
Fluid leak 4
Migration of device or device component 4
Device Issue 4
Obstruction within device 4
Implant, removal of 3
Material separation 3
Restricted flowrate 3
Deployment issue 3
Detachment of device or device component 2
Foreign material present in device 2
Material Distortion 2
Material integrity issue 2
Therapeutic or diagnostic output failure 2
Unintended movement 2
Not Applicable 2
Material frayed 2
Crack 2
Failure to Adhere or Bond 2
Break 2
Unsealed device packaging 2
Material puncture 2
Rupture due to damage from surgical instrument 2
Valve(s), failure of 2
End of prosthetic life 2
Cut in material 2
Valve(s), defective 2
Bacterial contamination of device 2
Component missing 1
Out-of-box failure 1
Fungus in device environment 1
Defective component 1
Invalid sensing 1
Air eliminator, defective 1
Suture line disruption 1
Device inoperable 1
Repair 1
Reflux within device 1
Device remains activated 1
Particulates 1
Difficult to position 1
Premature explantation 1
Increase in pressure 1
Loose or intermittent connection 1
Device abrasion from instrument or another object 1
Material invagination 1
Kinked 1
Burst 1
Bent 1
Coagulation in device or device ingredient 1
Component(s), broken 1
Material fragmentation 1
Difficult to deploy 1
Entrapment of device or device component 1
Positioning Issue 1
Naturally worn 1
Device packaging compromised 1
Defective item 1
Split 1
Aspiration issue 1
Total Device Problems 3673

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

-
-