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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 15

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 1000
Calcified 812
No Known Device Problem 628
No code available 481
Perivalvular leak 360
Degraded 286
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 93
Incomplete coaptation 51
Other (for use when an appropriate device code cannot be identified) 49
Leak 49
Restricted flowrate 49
Torn material 41
Gradient increase 40
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 15
Material deformation 11
Occlusion within device 8
Hole in material 7
Patient-device incompatibility 7
Difficult to open or close 7
Foreign material present in device 7
Device operates differently than expected 6
Fracture 6
Particulates 6
Tears, rips, holes in device, device material 6
Inadequate user interface 5
Malposition of device 5
Improper flow or infusion 4
Dislodged or dislocated 4
Structural problem 4
Unsealed device packaging 4
Mechanical issue 3
Detachment of device component 3
Break 3
Cut in material 3
Material perforation 3
Improper or incorrect procedure or method 3
Use of Device Issue 2
Fungus in device environment 2
End of prosthetic life 2
Escape 2
Contamination during use 2
Difficult to fold or unfold 2
Kinked 2
Paravalvular leak(s) 2
Sticking 2
Retraction problem 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Material Distortion 1
Not Applicable 1
Material rupture 1
Material separation 1
Unraveled material 1
Failure to unfold or unwrap 1
Difficult to position 1
Device abrasion from instrument or another object 1
Looping 1
Leaflet disc escape 1
Difficult to insert 1
Material fragmentation 1
Material frayed 1
Entrapment of device or device component 1
Bent 1
Coagulation in device or device ingredient 1
Human-Device Interface Issue 1
Folded 1
Leaflet disruption due to suture abrasion 1
Buckled material 1
Delivery system failure 1
Device disinfection or sterilization issue 1
Device damaged prior to use 1
Implant, removal of 1
Inaccurate delivery 1
Device Issue 1
Malfunction 1
Vacuum, loss of 1
Total Device Problems 6110

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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