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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 2017
28 34 31 47 22 58 66 38 13 22 3

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 1397
Calcified 915
No code available 633
No Known Device Problem 633
Perivalvular leak 425
Degraded 386
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 110
Incomplete coaptation 86
Gradient increase 73
Restricted flowrate 59
Torn material 54
Leak 51
Other (for use when an appropriate device code cannot be identified) 49
Material deformation 24
Fibrosis 21
Material rigid or stiff 20
Leaflet disruption, cause unknown 19
Malposition of device 11
Dislodged or dislocated 11
Difficult to open or close 10
Patient-device incompatibility 10
Occlusion within device 9
Foreign material present in device 8
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
Contamination during use 5
Inadequate user interface 5
Improper flow or infusion 4
Detachment of device component 4
Kinked 4
Retraction problem 4
Unsealed device packaging 4
Structural problem 4
Cut in material 3
Material perforation 3
Improper or incorrect procedure or method 3
Folded 3
Mechanical issue 3
Material rupture 3
Break 3
Bent 2
Sticking 2
Paravalvular leak(s) 2
Delivery system failure 2
Deployment issue 2
Escape 2
Use of Device Issue 2
Fungus in device environment 2
End of prosthetic life 2
Not Applicable 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Material Distortion 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
Human-Device Interface Issue 1
Device or device component damaged by another device 1
Device disinfection or sterilization issue 1
Buckled material 1
Leaflet disruption due to suture abrasion 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 7104

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 0 0
Class III 0 0 1 0 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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