• 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 mitral valve repair devices
Definition To repair the mitral valve by coapting the valve leaflets to prevent mitral regurgitation. These devices are different from the classified device (annuloplasty rings) in that a cardiotomy is not required to place them, some of them are placed percutaneously, and they definitely are not rings that are sewn on to the valve annulus.
Product CodeNKM
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
0 0 0 0 0 0 1 8 5 3

Device Problems
Incomplete coaptation 69
No Known Device Problem 47
Failure to Adhere or Bond 45
Difficult to remove 38
Difficult to position 36
Detachment of device component 30
Mechanical jam 20
Improper or incorrect procedure or method 18
Bent 17
Physical resistance 17
Break 16
Difficult to open or close 15
Mechanical issue 11
Leak 10
Device operates differently than expected 10
Device or device component damaged by another device 10
Difficult to deploy 7
Entrapment of device or device component 7
Failure to deploy 6
Difficult to insert 4
Knotted 4
Loose or intermittent connection 2
Kinked 2
Torn material 2
No Information 2
Material Protrusion 1
Deployment issue 1
Failure to advance 1
Failure to separate 1
Crack 1
Stretched 1
Unstable 1
Total Device Problems 452

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 0 0 1
Class II 0 0 0 0 0 0 0 0 0 0
Class III 0 0 0 0 0 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Vascular I Mar-07-2016

-
-