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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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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 2017
34 48 54 53 68 62 53 81 53 48 9

Device Problems
Leak 6117
Occlusion within device 1447
Migration of device or device component 1200
No Known Device Problem 1163
Other (for use when an appropriate device code cannot be identified) 753
Failure to Adhere or Bond 620
Inaccurate delivery 552
Kinked 524
Difficult to remove 377
Difficult to deploy 318
Difficult to position 311
Hole in material 269
Malposition of device 232
Implant, removal of 225
Break 214
No Information 152
Deployment issue 134
Detachment of device component 113
Explanted 105
Failure to deploy 96
Dissection 95
Failure to advance 92
Material separation 92
Use of Device Issue 82
Material perforation 80
Unintended movement 58
Material rupture 54
Rupture due to trauma 49
Failure to unfold or unwrap 49
Device operates differently than expected 47
Unknown (for use when the device problem is not known) 47
No code available 43
Fracture 39
Disconnection 37
Folded 37
Improper or incorrect procedure or method 36
Difficult to advance 33
User used incorrect product for intended use 31
Stretched 30
Detachment of device or device component 30
Material deformation 30
Difficult to insert 29
Size incorrect for patient 27
Torn material 24
Not Applicable 22
Collapse 22
Component(s), broken 22
Blockage within device or device component 21
Device expiration issue 21
Positioning Issue 19
Dislodged or dislocated 18
Fluid leak 18
Misplacement 18
Inability to irrigate 18
Patient-device incompatibility 18
Device or device component damaged by another device 15
Failure to separate 14
Retraction problem 14
Physical resistance 13
Defective item 13
Premature deployment 12
Material twisted 12
Material frayed 11
Strut fracture 11
Tears, rips, holes in device, device material 11
Device remains implanted 10
Burst 9
Twisting 8
Component or accessory incompatibility 8
Slippage of device or device component 7
Bent 7
Material fragmentation 6
Entrapment of device or device component 6
Material invagination 6
Sticking 6
Device damaged prior to use 6
Defective component 6
Device Issue 6
Packaging issue 6
Foreign material present in device 6
Failure to expand 6
Obstruction within device 5
Occlusion, incorrect 5
Contamination during use 5
Displacement 4
Unintended collision 4
Device maintenance issue 4
Wire(s), breakage of 4
Device-device incompatibility 4
Device markings issue 4
Bacterial contamination of device 4
Seal, incorrect 4
Tip breakage 4
Device, or device fragments remain in patient 4
Rupture, cause unknown 4
Pressure issue 4
Incompatibility problem 4
Therapeutic or diagnostic output failure 3
Failure to align 3
Device, removal of (non-implant) 3
Total Device Problems 16621

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 0
Class II 0 1 0 0 0 2 1 1 1 0 7
Class III 0 0 0 0 1 0 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 Endologix II Jan-19-2017
4 Endologix II Jan-19-2017
5 Endologix II Jan-19-2017
6 Endologix II Jan-19-2017
7 Endologix II Jan-18-2017
8 Endologix II Jan-18-2017
9 Endologix II Jan-18-2017
10 Medtronic CardioVascular II Apr-08-2008
11 Medtronic Vascular, Inc. II Oct-25-2013
12 Medtronic Vascular, Inc. II Mar-23-2012
13 Trivascular, Inc I Nov-03-2014
14 Trivascular, Inc II Mar-26-2014
15 Trivascular, Inc II Nov-13-2012

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