TPLC - Total Product Life Cycle

• Device: heart-valve, non-allograft tissue
• Product Code: LWR
• Device Class: 3

Premarket Approvals (PMA)
2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
8	7	15	17	25	18	31	27	14	27	20

Device Problems
Unknown (for use when the device problem is not known)	1550
Explanted	288
No Information	285
No Known Device Problem	237
Paravalvular leak	215
Deterioration of prosthesis	179
Gradient increase	169
Other (for use when an appropriate device code cannot be identified)	142
Perivalvular leak	138
Performance	94
Tears, rips, holes in device, device material	91
Calcified	88
Incomplete coaptation	77
Replace	76
Device operates differently than expected	49
Mineralization	45
Torn material	39
Size incorrect for patient	35
Malposition of device	31
Structural problem	30
Leak	26
Leaflet disruption, cause unknown	23
Material deformation	22
Material rigid or stiff	22
No code available	21
Patient-device incompatibility	19
Leaflet disruption due to suture abrasion	18
Human-Device Interface Issue	18
Material perforation	16
Hole in material	13
Device remains implanted	11
Material rupture	11
Dislodged or dislocated	11
Obstruction within device	10
Paravalvular leak(s)	10
Detachment of device component	9
Improper or incorrect procedure or method	9
Degraded	8
Kinked	8
Occlusion within device	7
Use of Device Issue	7
Fluid leak	6
Fibrosis	6
Folded	5
Fracture	5
Migration of device or device component	5
Bacterial contamination of device	5
Device Issue	4
Material separation	4
Deployment issue	4
Material Distortion	4
Material integrity issue	3
Implant, removal of	3
Restricted flowrate	3
Bent	3
Break	3
Crack	2
Material invagination	2
Failure to Adhere or Bond	2
Material frayed	2
Unsealed device packaging	2
Material puncture	2
Cut in material	2
End of prosthetic life	2
Valve(s), defective	2
Rupture due to damage from surgical instrument	2
Valve(s), failure of	2
Foreign material present in device	2
Difficult to open or close	2
Unintended movement	2
Not Applicable	2
Positioning Issue	2
Therapeutic or diagnostic output failure	2
Detachment of device or device component	2
Device packaging compromised	1
Aspiration issue	1
Biological environmental factor	1
Buckled material	1
Capturing issue	1
Delivery system failure	1
Defective item	1
Split	1
Device handling issue	1
Naturally worn	1
Device inoperable	1
Defective component	1
Invalid sensing	1
Shelf life exceeded	1
Stretched	1
Suture line disruption	1
Air eliminator, defective	1
Component missing	1
Out-of-box failure	1
Fungus in device environment	1
Reflux within device	1
Device remains activated	1
Repair	1
Difficult to position	1
Premature explantation	1
Device Difficult to Setup or Prepare	1
Total Device Problems	4282

Recalls
	2007	2008	2009	2010	2011	2012	2013	2014	2015	2016	2017
Class I	0	0	0	0	0	0	0	0	0	0	0
Class II	0	0	0	0	0	0	0	1	0	1	0
Class III	0	0	0	0	0	0	0	0	0	0	0

Recalls
Manufacturer		Recall Class	Date Posted
1	Medtronic Cardiovascular Surgery-the Heart Valve Division	II	Feb-03-2014
2	Sorin Group USA, Inc.	II	Dec-07-2016