• 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 system, endovascular graft, aortic aneurysm treatment
Product CodeMIH
Device Class 3

Premarket Approvals (PMA)
2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
34 48 54 53 68 62 53 81 53 28

Device Problems
Leak 5046
Occlusion within device 1263
Migration of device or device component 1033
No Known Device Problem 919
Other (for use when an appropriate device code cannot be identified) 751
Inaccurate delivery 552
Kinked 493
Failure to Adhere or Bond 354
Difficult to remove 342
Difficult to position 287
Difficult to deploy 284
Implant, removal of 225
Break 185
No Information 131
Hole in material 123
Malposition of device 120
Explanted 105
Dissection 94
Failure to deploy 80
Material perforation 80
Deployment issue 79
Material separation 69
Use of Device Issue 63
Detachment of device component 61
Material rupture 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Failure to unfold or unwrap 44
Disconnection 37
Device operates differently than expected 35
Detachment of device or device component 27
Stretched 25
Improper or incorrect procedure or method 24
Folded 24
Component(s), broken 22
Size incorrect for patient 21
Not Applicable 21
Difficult to advance 20
Misplacement 18
Device expiration issue 17
Difficult to insert 17
Failure to advance 16
Positioning Issue 15
Fracture 15
Material deformation 14
Patient-device incompatibility 14
No code available 14
Physical resistance 13
User used incorrect product for intended use 13
Retraction problem 12
Fluid leak 12
Defective item 11
Dislodged or dislocated 11
Strut fracture 11
Tears, rips, holes in device, device material 11
Material twisted 11
Failure to separate 10
Device remains implanted 10
Premature deployment 10
Inability to irrigate 8
Twisting 8
Slippage of device or device component 7
Device or device component damaged by another device 7
Blockage within device or device component 7
Component or accessory incompatibility 6
Foreign material present in device 6
Sticking 6
Device Issue 6
Obstruction within device 5
Burst 5
Entrapment of device or device component 5
Occlusion, incorrect 5
Unintended movement 5
Failure to expand 4
Device maintenance issue 4
Rupture, cause unknown 4
Device, or device fragments remain in patient 4
Unintended collision 4
Displacement 4
Collapse 4
Contamination during use 4
Wire(s), breakage of 4
Bacterial contamination of device 4
Device damaged prior to use 4
Defective component 4
Tip breakage 4
Seal, incorrect 4
Pressure issue 4
Therapeutic or diagnostic output failure 3
Device-device incompatibility 3
Device, removal of (non-implant) 3
Bent 3
Dislodged 3
Material fragmentation 3
Reaction 3
Product quality issue 2
Material invagination 2
Mechanical issue 2
Foreign material 2
Dislocated 2
Total Device Problems 13637

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
Class I 0 0 0 0 0 0 0 1 0 0
Class II 0 1 0 0 0 2 1 1 1 0
Class III 0 0 0 0 1 0 0 0 0 0

Recalls
Manufacturer Recall Class Date Posted
1 Bard Peripheral Vascular Inc II Nov-05-2015
2 Cook, Inc. III Sep-06-2011
3 Medtronic CardioVascular II Apr-08-2008
4 Medtronic Vascular, Inc. II Oct-25-2013
5 Medtronic Vascular, Inc. II Mar-23-2012
6 Trivascular, Inc I Nov-03-2014
7 Trivascular, Inc II Mar-26-2014
8 Trivascular, Inc II Nov-13-2012

-
-