| Device |
system, endovascular graft, aortic aneurysm treatment |
| Product Code | MIH |
| Device Class |
3
|
| Premarket Approvals (PMA) |
| 2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
|
34
|
48
|
54
|
53
|
68
|
62
|
16
|
|
| Device Problems |
| Leak |
3834 |
| Occlusion within device |
1054 |
| Migration of device or device component |
847 |
| Other (for use when an appropriate device code cannot be identified) |
734 |
| No Known Device Problem |
659 |
| Inaccurate delivery |
551 |
| Kinked |
462 |
| Difficult to remove |
292 |
| Difficult to position |
270 |
| Difficult to deploy |
263 |
| Implant, removal of |
224 |
| Explanted |
90 |
| Dissection |
87 |
| Break |
86 |
| Material perforation |
80 |
| Rupture due to trauma |
49 |
| Use of Device Issue |
48 |
| Unknown (for use when the device problem is not known) |
47 |
| Material rupture |
43 |
| Failure to unfold or unwrap |
38 |
| Disconnection |
33 |
| Material separation |
30 |
| No Information |
22 |
| Component(s), broken |
21 |
| Misplacement |
17 |
| Folded |
17 |
| Not Applicable |
16 |
| Device expiration issue |
15 |
| Strut fracture |
11 |
| Tears, rips, holes in device, device material |
10 |
| Defective item |
10 |
| Device remains implanted |
10 |
| Detachment of device component |
10 |
| Detachment of device or device component |
9 |
| Failure to deploy |
9 |
| Twisting |
8 |
| Difficult to insert |
8 |
| Material twisted |
8 |
| Size incorrect for patient |
7 |
| Device Issue |
6 |
| Component or accessory incompatibility |
5 |
| Failure to advance |
5 |
| Device maintenance issue |
4 |
| Defective component |
4 |
| Seal, incorrect |
4 |
| Device, or device fragments remain in patient |
4 |
| Foreign material present in device |
3 |
| Device, removal of (non-implant) |
3 |
| Displacement |
3 |
| Tip breakage |
3 |
| Fracture |
3 |
| Material deformation |
3 |
| Reaction |
3 |
| Device damaged prior to use |
3 |
| Collapse |
2 |
| Sticking |
2 |
| User used incorrect product for intended use |
2 |
| Air eliminator, defective |
2 |
| Physical resistance |
2 |
| Foreign material |
2 |
| Wire(s), breakage of |
2 |
| Inability to irrigate |
2 |
| Dislodged or dislocated |
2 |
| Material invagination |
2 |
| Bacterial contamination of device |
2 |
| Device operates differently than expected |
1 |
| Gel leak |
1 |
| Retraction problem |
1 |
| Hole in material |
1 |
| Interlumen communication |
1 |
| Incomplete or missing packaging |
1 |
| Surgical graft, failure of |
1 |
| Difficult or delayed activation |
1 |
| Premature deployment |
1 |
| Deflation issue |
1 |
| Disengaged |
1 |
| Perivalvular leak |
1 |
| Unintended movement |
1 |
| Product quality issue |
1 |
| Deployment issue |
1 |
| Unintended magnet quench |
1 |
| Incorrect measurement |
1 |
| Material opacification |
1 |
| Valve(s), failure of |
1 |
| Haptic Stuck in Delivery System |
1 |
| Burst |
1 |
| Dislocated |
1 |
| Crack |
1 |
| Malfunction |
1 |
| Improper or incorrect procedure or method |
1 |
| Expulsion |
1 |
| Lead(s), fracture of |
1 |
| Vacuum, loss of |
1 |
| Dislodged |
1 |
| Disposable |
1 |
| Cannula Guide, Needle Insertion Difficult |
1 |
| Lens, cloudy |
1 |
| Bent |
1 |
| Malposition of device |
1 |
| Device or device fragments location unknown |
1 |
| Total Device Problems |
10142 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
1 |
0 |
0 |
0 |
2 |
0 |
| Class III |
0 |
0 |
0 |
0 |
1 |
0 |
0 |
|
|
|
