TPLC - Total Product Life Cycle

• Device: stent, iliac
• Definition: Stent, Iliac -- a metal scaffold placed via a delivery catheter into the iliac artery to maintain the lumen
• Product Code: NIO
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
3	4	7	14	23	34	15

Device Problems
Premature deployment	106
Dislodged or dislocated	69
Inaccurate delivery	60
No Known Device Problem	54
Deployment issue	42
Difficult to deploy	34
Difficult to remove	23
Occlusion within device	21
Migration of device or device component	18
Dislodged	17
Device remains implanted	17
Failure to advance	17
Material frayed	16
Difficult to position	13
Other (for use when an appropriate device code cannot be identified)	12
Material separation	12
Size incorrect for patient	12
Split	11
Fracture	11
Unknown (for use when the device problem is not known)	9
Detachment of device or device component	9
Unintended movement	9
Material deformation	8
Delivery system failure	8
Material rupture	8
Torn material	7
Difficult to advance	6
Material Distortion	6
Device operates differently than expected	6
Malposition of device	6
Physical resistance	6
Failure to deploy	6
Bent	6
Break	6
Detachment of device component	5
Device damaged prior to use	5
Tip breakage	5
Not Applicable	5
No code available	4
Incorrect or inadequate result	4
Device, or device fragments remain in patient	4
Crack	4
Difficult to insert	4
Interference	4
Loose	4
Unsealed device packaging	4
Kinked	3
Deflation issue	3
Entrapment of device or device component	3
Resistance, inadequate	3
Failure to deliver	3
Sticking	3
Packaging issue	3
Device markings issue	2
Defective item	2
Device, removal of (non-implant)	2
Unstable	2
Shaft break	2
Device expiration issue	2
Balloon rupture	2
Loose or intermittent connection	2
Hole in material	2
Inflation issue	1
Leak	1
Mislabeled	1
Misplacement	1
Delivered as unsterile product	1
Balloon burst	1
Bleed back	1
Application interface becomes non-functional or program exits abnormally	1
Foreign material	1
Displacement	1
Dissection	1
Failure to Adhere or Bond	1
Slippage of device or device component	1
Sterility	1
Use of Device Issue	1
Insufficient flow or underinfusion	1
Device Difficult to Setup or Prepare	1
Therapy delivered to incorrect body area	1
Balloon pinhole	1
Catheter withdrawal interference	1
Tipover	1
Device or device fragments location unknown	1
Tears, rips, holes in device, device material	1
Material perforation	1
Tear, rip or hole in device packaging	1
Device or device component damaged by another device	1
No flow	1
Positioning Issue	1
Total Device Problems	790

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	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Cook Ireland Ltd.	II	Sep-01-2012
2	Cordis Corporation	II	Feb-15-2012
3	Cordis Corporation	II	Jul-31-2008