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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 14

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 919
Calcified 792
No Known Device Problem 625
No code available 465
Perivalvular leak 354
Degraded 265
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 93
Leak 49
Incomplete coaptation 49
Other (for use when an appropriate device code cannot be identified) 49
Restricted flowrate 42
Torn material 40
Gradient increase 32
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 13
Material deformation 10
Occlusion within device 8
Patient-device incompatibility 7
Foreign material present in device 7
Device operates differently than expected 6
Difficult to open or close 6
Tears, rips, holes in device, device material 6
Hole in material 6
Fracture 6
Particulates 5
Inadequate user interface 5
Malposition of device 5
Improper flow or infusion 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
Dislodged or dislocated 3
Escape 2
Retraction problem 2
Fungus in device environment 2
End of prosthetic life 2
Contamination during use 2
Kinked 2
Paravalvular leak(s) 2
Use of Device Issue 2
Sticking 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Material Distortion 1
Not Applicable 1
Material rupture 1
Vacuum, loss of 1
Unraveled material 1
Failure to unfold or unwrap 1
Looping 1
Difficult to position 1
Leaflet disc escape 1
Difficult to insert 1
Material frayed 1
Difficult to fold or unfold 1
Entrapment of device or device component 1
Bent 1
Coagulation in device or device ingredient 1
Implant, removal of 1
Inaccurate delivery 1
Device Issue 1
Malfunction 1
Device damaged prior to use 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
Total Device Problems 5934

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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