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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 1

Device Problems
Unknown (for use when the device problem is not known) 1537
Calcified 719
No Information 676
No Known Device Problem 619
No code available 432
Perivalvular leak 324
Deterioration of prosthesis 208
Paravalvular leak 203
Degraded 193
Size incorrect for patient 89
Other (for use when an appropriate device code cannot be identified) 49
Restricted flowrate 40
Leak 37
Incomplete coaptation 37
Torn material 26
Gradient increase 26
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 13
Material deformation 7
Patient-device incompatibility 6
Device operates differently than expected 6
Foreign material present in device 6
Tears, rips, holes in device, device material 6
Hole in material 6
Fracture 6
Occlusion within device 5
Inadequate user interface 5
Unsealed device packaging 4
Particulates 4
Difficult to open or close 4
Malposition of device 4
Improper flow or infusion 4
Structural problem 4
Cut in material 3
Material perforation 3
Mechanical issue 3
Improper or incorrect procedure or method 3
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
Fungus in device environment 2
End of prosthetic life 2
Escape 2
Positioning Issue 2
Device handling issue 2
Failure to expand 1
Not Applicable 1
Material Distortion 1
Folded 1
Delivery system failure 1
Device disinfection or sterilization issue 1
Dislodged or dislocated 1
Human-Device Interface Issue 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
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
Total Device Problems 5408

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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