TPLC - Total Product Life Cycle

• Device: stent, superficial femoral artery
• Definition: Stent, Superficial Femoral Artery -- a metal scaffold placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen
• Product Code: NIP
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013
5	4	21	19	16	16	6

Device Problems
Fracture	24
Device remains implanted	19
Premature deployment	13
Difficult to deploy	12
Difficult to remove	9
Size incorrect for patient	9
Occlusion within device	8
Failure to deploy	8
Break	8
Strut fracture	5
Deployment issue	5
Failure to advance	4
Other (for use when an appropriate device code cannot be identified)	3
Unknown (for use when the device problem is not known)	3
Device damaged prior to use	3
Difficult to position	3
Detachment of device component	3
No Information	2
Dislodged	2
Tip breakage	2
Sticking	2
Inaccurate delivery	2
Device operates differently than expected	2
Material torqued	1
Material twisted	1
Detachment of device or device component	1
Structural problem	1
Device, removal of (non-implant)	1
Failure to deliver	1
Entrapment of device or device component	1
Failure to capture	1
Difficult to insert	1
Kinked	1
Regenerate	1
Resistance, inadequate	1
Material separation	1
Total Device Problems	164

Recalls
	2007	2008	2009	2010	2011	2012	2013
Class I	0	0	0	0	1	0	0
Class II	0	0	0	0	0	0	0
Class III	0	2	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Boston Scientific Corporation	I	Jun-16-2011
2	Ev3, Inc	III	Sep-21-2008
3	Ev3, Inc	III	Sep-11-2008