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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 37

Device Problems
Leak 7331
Occlusion within device 1633
No Known Device Problem 1405
Migration of device or device component 1378
Failure to Adhere or Bond 897
Other (for use when an appropriate device code cannot be identified) 753
Inaccurate delivery 552
Kinked 549
Hole in material 477
Difficult to remove 407
Malposition of device 342
Difficult to position 340
Difficult to deploy 339
Break 249
Implant, removal of 225
Deployment issue 178
Detachment of device component 175
No Information 158
Unintended movement 121
Failure to deploy 109
Explanted 105
Failure to advance 104
Material separation 101
Dissection 95
Use of Device Issue 90
Material perforation 81
Stretched 81
Improper or incorrect procedure or method 78
Fracture 68
No code available 63
User used incorrect product for intended use 59
Device operates differently than expected 58
Material rupture 57
Failure to unfold or unwrap 54
Folded 53
Material integrity issue 50
Rupture due to trauma 49
Unknown (for use when the device problem is not known) 47
Patient-device incompatibility 47
Device or device component damaged by another device 47
Material deformation 43
Collapse 41
Blockage within device or device component 40
Disconnection 39
Difficult to advance 37
Torn material 36
Detachment of device or device component 36
Size incorrect for patient 34
Difficult to insert 34
Fluid leak 32
Dislodged or dislocated 32
Device expiration issue 24
Inability to irrigate 24
Not Applicable 23
Positioning Issue 23
Component(s), broken 22
Failure to separate 21
Defective item 20
Misplacement 18
Material twisted 17
Retraction problem 16
Physical resistance 15
Material frayed 14
Premature deployment 12
Component or accessory incompatibility 11
Strut fracture 11
Tears, rips, holes in device, device material 11
Device remains implanted 10
Human-Device Interface Issue 10
Burst 9
Bent 9
Entrapment of device or device component 9
Twisting 8
Slippage of device or device component 7
Device markings issue 7
Material fragmentation 7
Material invagination 7
Packaging issue 7
Failure to expand 7
Foreign material present in device 6
Bacterial contamination of device 6
Device Issue 6
Sticking 6
Device damaged prior to use 6
Defective component 6
Obstruction within device 5
Occlusion, incorrect 5
Loss of or failure to bond 5
Contamination during use 5
Incompatibility problem 5
Manufacturing or shipping issue associated with device 4
Device-device incompatibility 4
Pressure issue 4
Filling problem 4
Flaked 4
Displacement 4
Unintended collision 4
Material puncture 4
Device maintenance issue 4
Wire(s), breakage of 4
Total Device Problems 19889

Recalls
  2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017
Class I 0 0 0 0 0 0 0 1 0 0 1
Class II 0 1 0 0 0 2 1 1 1 0 9
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 Medical Incorporated I Aug-10-2017
3 Cook, Inc. III Sep-06-2011
4 Endologix II Jan-19-2017
5 Endologix II Jan-19-2017
6 Endologix II Jan-19-2017
7 Endologix II Jan-19-2017
8 Endologix II Jan-18-2017
9 Endologix II Jan-18-2017
10 Endologix II Jan-18-2017
11 Medtronic CardioVascular II Apr-08-2008
12 Medtronic Vascular, Inc. II Mar-15-2017
13 Medtronic Vascular, Inc. II Oct-25-2013
14 Medtronic Vascular, Inc. II Mar-23-2012
15 Trivascular, Inc I Nov-03-2014
16 Trivascular, Inc II Mar-26-2014
17 Trivascular, Inc II Nov-13-2012
18 W L Gore & Associates, Inc. II Oct-25-2017

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