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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 17

Device Problems
No Information 1749
Unknown (for use when the device problem is not known) 1537
Calcified 1040
No code available 903
No Known Device Problem 632
Degraded 479
Perivalvular leak 467
Deterioration of prosthesis 208
Paravalvular leak 203
Incomplete coaptation 134
Size incorrect for patient 111
Gradient increase 98
Restricted flowrate 75
Torn material 68
Leak 51
Other (for use when an appropriate device code cannot be identified) 49
Material deformation 30
Fibrosis 21
Material rigid or stiff 21
Leaflet disruption, cause unknown 19
Dislodged or dislocated 11
Difficult to open or close 10
Malposition of device 10
Patient-device incompatibility 10
Occlusion within device 9
Hole in material 8
Device operates differently than expected 8
Foreign material present in device 8
Difficult to fold or unfold 6
Fracture 6
Particulates 6
Tears, rips, holes in device, device material 6
Inadequate user interface 5
Improper flow or infusion 4
Retraction problem 4
Unsealed device packaging 4
Detachment of device component 4
Folded 4
Structural problem 4
Cut in material 3
Material perforation 3
Improper or incorrect procedure or method 3
Break 3
Mechanical issue 3
Material Distortion 3
Not Applicable 2
Positioning Issue 2
Paravalvular leak(s) 2
Material rupture 2
Sticking 2
Bent 2
Contamination during use 2
Kinked 2
Use of Device Issue 2
Fungus in device environment 2
End of prosthetic life 2
Delivery system failure 2
Deployment issue 2
Escape 2
Human-Device Interface Issue 1
Device or device component damaged by another device 1
Device disinfection or sterilization issue 1
Connection issue 1
Delamination 1
Leaflet disruption due to suture abrasion 1
Device damaged prior to use 1
Implant, removal of 1
Inaccurate delivery 1
Device Issue 1
Tear, rip or hole in device packaging 1
Malfunction 1
Obstruction within device 1
Vacuum, loss of 1
Leaflet disc escape 1
Difficult to insert 1
Material fragmentation 1
Material frayed 1
Material discolored 1
Entrapment of device or device component 1
Coagulation in device or device ingredient 1
Unraveled material 1
Failure to unfold or unwrap 1
Material separation 1
Difficult to position 1
Loss of power 1
Device abrasion from instrument or another object 1
Migration of device or device component 1
Looping 1
Sediment, precipitate or deposit in device or device ingredient 1
Device handling issue 1
Failure to expand 1
Total Device Problems 8100

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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