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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 20

Device Problems
Leak 6604
Occlusion within device 1520
Migration of device or device component 1292
No Known Device Problem 1281
Other (for use when an appropriate device code cannot be identified) 753
Failure to Adhere or Bond 746
Inaccurate delivery 552
Kinked 533
Difficult to remove 390
Hole in material 363
Difficult to deploy 328
Difficult to position 326
Malposition of device 278
Break 240
Implant, removal of 225
No Information 156
Deployment issue 154
Detachment of device component 143
Explanted 105
Failure to deploy 101
Material separation 96
Dissection 95
Failure to advance 93
Use of Device Issue 86
Unintended movement 82
Material perforation 80
Material rupture 55
No code available 51
Failure to unfold or unwrap 50
Rupture due to trauma 49
Fracture 48
Device operates differently than expected 48
Unknown (for use when the device problem is not known) 47
Folded 43
User used incorrect product for intended use 42
Improper or incorrect procedure or method 39
Disconnection 37
Difficult to advance 35
Material deformation 35
Stretched 34
Detachment of device or device component 33
Difficult to insert 33
Size incorrect for patient 31
Collapse 29
Torn material 29
Device or device component damaged by another device 27
Blockage within device or device component 27
Patient-device incompatibility 26
Fluid leak 24
Dislodged or dislocated 23
Component(s), broken 22
Not Applicable 22
Positioning Issue 21
Device expiration issue 21
Inability to irrigate 21
Failure to separate 19
Misplacement 18
Retraction problem 15
Physical resistance 14
Defective item 14
Material frayed 14
Material twisted 13
Premature deployment 12
Strut fracture 11
Tears, rips, holes in device, device material 11
Device remains implanted 10
Component or accessory incompatibility 9
Burst 9
Twisting 8
Slippage of device or device component 7
Bent 7
Material invagination 7
Packaging issue 7
Foreign material present in device 6
Failure to expand 6
Material fragmentation 6
Entrapment of device or device component 6
Sticking 6
Device damaged prior to use 6
Defective component 6
Device Issue 6
Obstruction within device 5
Device markings issue 5
Contamination during use 5
Occlusion, incorrect 5
Unintended collision 4
Device maintenance issue 4
Loss of or failure to bond 4
Displacement 4
Wire(s), breakage of 4
Bacterial contamination of device 4
Tip breakage 4
Device, or device fragments remain in patient 4
Seal, incorrect 4
Rupture, cause unknown 4
Pressure issue 4
Device-device incompatibility 4
Incompatibility problem 4
Material integrity issue 4
Device, removal of (non-implant) 3
Total Device Problems 17956

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 8
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 Mar-15-2017
12 Medtronic Vascular, Inc. II Oct-25-2013
13 Medtronic Vascular, Inc. II Mar-23-2012
14 Trivascular, Inc I Nov-03-2014
15 Trivascular, Inc II Mar-26-2014
16 Trivascular, Inc II Nov-13-2012

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