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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 846
Calcified 774
No Known Device Problem 621
No code available 458
Perivalvular leak 348
Degraded 249
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 89
Other (for use when an appropriate device code cannot be identified) 49
Leak 46
Incomplete coaptation 44
Restricted flowrate 42
Torn material 38
Gradient increase 32
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 13
Material deformation 8
Foreign material present in device 7
Patient-device incompatibility 7
Occlusion within device 7
Tears, rips, holes in device, device material 6
Hole in material 6
Fracture 6
Device operates differently than expected 6
Difficult to open or close 6
Inadequate user interface 5
Improper flow or infusion 4
Malposition of device 4
Structural problem 4
Unsealed device packaging 4
Particulates 4
Mechanical issue 3
Improper or incorrect procedure or method 3
Cut in material 3
Material perforation 3
Fungus in device environment 2
End of prosthetic life 2
Dislodged or dislocated 2
Escape 2
Retraction problem 2
Use of Device Issue 2
Sticking 2
Paravalvular leak(s) 2
Detachment of device component 2
Contamination during use 2
Break 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Not Applicable 1
Bent 1
Coagulation in device or device ingredient 1
Difficult to fold or unfold 1
Material frayed 1
Looping 1
Difficult to insert 1
Kinked 1
Leaflet disc escape 1
Material rupture 1
Difficult to position 1
Unraveled material 1
Failure to unfold or unwrap 1
Vacuum, loss of 1
Buckled material 1
Delivery system failure 1
Device disinfection or sterilization issue 1
Folded 1
Human-Device Interface Issue 1
Material Distortion 1
Leaflet disruption due to suture abrasion 1
Implant, removal of 1
Inaccurate delivery 1
Device Issue 1
Malfunction 1
Device damaged prior to use 1
Total Device Problems 5786

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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