• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
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 0

Device Problems
Unknown (for use when the device problem is not known) 1537
No Information 1349
Calcified 897
No Known Device Problem 633
No code available 595
Perivalvular leak 415
Degraded 367
Deterioration of prosthesis 208
Paravalvular leak 203
Size incorrect for patient 110
Incomplete coaptation 73
Gradient increase 69
Restricted flowrate 57
Torn material 53
Leak 50
Other (for use when an appropriate device code cannot be identified) 49
Material deformation 24
Fibrosis 21
Leaflet disruption, cause unknown 19
Material rigid or stiff 18
Malposition of device 11
Dislodged or dislocated 11
Difficult to open or close 10
Patient-device incompatibility 10
Occlusion within device 9
Hole in material 7
Foreign material present in device 7
Difficult to fold or unfold 6
Particulates 6
Fracture 6
Device operates differently than expected 6
Tears, rips, holes in device, device material 6
Contamination during use 5
Inadequate user interface 5
Improper flow or infusion 4
Detachment of device component 4
Unsealed device packaging 4
Retraction problem 4
Structural problem 4
Improper or incorrect procedure or method 3
Folded 3
Mechanical issue 3
Cut in material 3
Material perforation 3
Break 3
Kinked 3
Positioning Issue 2
Fungus in device environment 2
Material rupture 2
End of prosthetic life 2
Paravalvular leak(s) 2
Delivery system failure 2
Device handling issue 2
Sticking 2
Bent 2
Escape 2
Deployment issue 2
Not Applicable 2
Use of Device Issue 2
Device abrasion from instrument or another object 1
Buckled material 1
Obstruction within device 1
Looping 1
Leaflet disruption due to suture abrasion 1
Unraveled material 1
Failure to expand 1
Coagulation in device or device ingredient 1
Material frayed 1
Human-Device Interface Issue 1
Device Issue 1
Device or device component damaged by another device 1
Material separation 1
Material fragmentation 1
Vacuum, loss of 1
Inaccurate delivery 1
Failure to unfold or unwrap 1
Implant, removal of 1
Leaflet disc escape 1
Difficult to position 1
Material Distortion 1
Entrapment of device or device component 1
Device disinfection or sterilization issue 1
Difficult to insert 1
Malfunction 1
Device damaged prior to use 1
Total Device Problems 6945

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

-
-