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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device replacement heart-valve
Regulation Description Replacement heart valve.
Definition Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product CodeDYE
Regulation Number 870.3925
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
28 34 31 47 22 58 66 38 13 21

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 1164
Calcified 851
No Known Device Problem 633
No code available 522
Perivalvular leak 384
Degraded 329
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 101
Gradient increase 61
Incomplete coaptation 56
Restricted flowrate 52
Leak 50
Other (for use when an appropriate device code cannot be identified) 49
Torn material 47
Material deformation 22
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 18
Occlusion within device 9
Patient-device incompatibility 9
Difficult to open or close 9
Malposition of device 8
Dislodged or dislocated 7
Foreign material present in device 7
Hole in material 7
Difficult to fold or unfold 6
Fracture 6
Particulates 6
Tears, rips, holes in device, device material 6
Device operates differently than expected 6
Inadequate user interface 5
Contamination during use 5
Detachment of device component 4
Unsealed device packaging 4
Improper flow or infusion 4
Structural problem 4
Cut in material 3
Material perforation 3
Improper or incorrect procedure or method 3
Mechanical issue 3
Retraction problem 3
Break 3
Kinked 3
Bent 2
Material rupture 2
Sticking 2
Paravalvular leak(s) 2
Use of Device Issue 2
Fungus in device environment 2
End of prosthetic life 2
Escape 2
Folded 2
Delivery system failure 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Material Distortion 1
Not Applicable 1
Deployment issue 1
Device disinfection or sterilization issue 1
Buckled material 1
Leaflet disruption due to suture abrasion 1
Human-Device Interface Issue 1
Device damaged prior to use 1
Implant, removal of 1
Inaccurate delivery 1
Device Issue 1
Malfunction 1
Obstruction within device 1
Vacuum, loss of 1
Difficult to position 1
Device abrasion from instrument or another object 1
Looping 1
Unraveled material 1
Failure to unfold or unwrap 1
Material separation 1
Coagulation in device or device ingredient 1
Entrapment of device or device component 1
Leaflet disc escape 1
Difficult to insert 1
Material fragmentation 1
Material frayed 1
Total Device Problems 6511

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 1 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Cardiovascular Surgery-the Heart Valve Division II Sep-11-2014
2 Medtronic Inc III May-29-2009

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