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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
28 34 31 47 19 55 23

Device Problems
Unknown (for use when the device problem is not known) 1536
No Known Device Problem 584
Calcified 432
Perivalvular leak 245
No code available 239
Deterioration of prosthesis 208
Paravalvular leak 203
No Information 186
Size incorrect for patient 79
Other (for use when an appropriate device code cannot be identified) 49
Degraded 39
Fibrosis 21
Incomplete coaptation 19
Leaflet disruption, cause unknown 19
Torn material 7
Tears, rips, holes in device, device material 6
Foreign material present in device 6
Inadequate user interface 5
Particulates 4
Hole in material 4
Unsealed device packaging 4
Material rigid or stiff 4
Patient-device incompatibility 4
Cut in material 3
Structural problem 3
Improper or incorrect procedure or method 3
Detachment of device component 2
Contamination during use 2
Leak 2
Positioning Issue 2
Fungus in device environment 2
End of prosthetic life 2
Use of Device Issue 2
Material perforation 2
Break 2
Paravalvular leak(s) 2
Fracture 2
Bent 1
Device Issue 1
Folded 1
Human-Device Interface Issue 1
Retraction problem 1
Gradient increase 1
Leaflet disc escape 1
Looping 1
Implant, removal of 1
Inaccurate delivery 1
Vacuum, loss of 1
Difficult to open or close 1
Dislodged or dislocated 1
Improper flow or infusion 1
Malfunction 1
Material frayed 1
Leaflet disruption due to suture abrasion 1
Malposition of device 1
Device disinfection or sterilization issue 1
Material rupture 1
Unraveled material 1
Device damaged prior to use 1
Sticking 1
Material deformation 1
Total Device Problems 3958

Recalls
  2007 2008 2009 2010 2011 2012 2013
Class I 0 0 0 0 0 0 0
Class II 0 0 0 0 0 0 0
Class III 0 0 1 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc III May-29-2009

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