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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 9

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 1522
Calcified 963
No code available 745
No Known Device Problem 632
Perivalvular leak 431
Degraded 413
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 107
Incomplete coaptation 98
Gradient increase 84
Restricted flowrate 67
Torn material 57
Leak 51
Other (for use when an appropriate device code cannot be identified) 49
Material deformation 25
Fibrosis 21
Material rigid or stiff 20
Leaflet disruption, cause unknown 19
Dislodged or dislocated 11
Difficult to open or close 10
Malposition of device 10
Patient-device incompatibility 10
Foreign material present in device 8
Occlusion within device 8
Hole in material 7
Device operates differently than expected 7
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
Structural problem 4
Cut in material 3
Material perforation 3
Improper or incorrect procedure or method 3
Folded 3
Break 3
Mechanical issue 3
Paravalvular leak(s) 2
Material rupture 2
Sticking 2
Bent 2
Contamination during use 2
Kinked 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
Material Distortion 1
Device handling issue 1
Failure to expand 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
Leaflet disruption due to suture abrasion 1
Leaflet disc escape 1
Difficult to insert 1
Material fragmentation 1
Material frayed 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
Device abrasion from instrument or another object 1
Migration of device or device component 1
Looping 1
Total Device Problems 7445

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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