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
8	7	15	17	28	21	17

Device Problems
Unknown (for use when the device problem is not known)	1550
Explanted	287
Paravalvular leak	215
Deterioration of prosthesis	179
Other (for use when an appropriate device code cannot be identified)	142
Performance	94
Tears, rips, holes in device, device material	91
Replace	76
No Known Device Problem	66
Calcified	66
Perivalvular leak	65
Gradient increase	46
Mineralization	45
Incomplete coaptation	35
Leaflet disruption, cause unknown	23
Malposition of device	22
Leaflet disruption due to suture abrasion	18
Human-Device Interface Issue	18
Structural problem	17
Leak	14
Device remains implanted	11
Patient-device incompatibility	11
Material perforation	10
Paravalvular leak(s)	10
No Information	7
Use of Device Issue	7
Detachment of device component	7
Improper or incorrect procedure or method	7
Fibrosis	6
Hole in material	6
Migration of device or device component	4
Device Issue	4
Fracture	4
Dislodged or dislocated	4
No code available	4
Deployment issue	3
Implant, removal of	3
Not Applicable	2
Obstruction within device	2
End of prosthetic life	2
Crack	2
Unsealed device packaging	2
Size incorrect for patient	2
Unintended movement	2
Rupture due to damage from surgical instrument	2
Suture line disruption	1
Difficult to deploy	1
Air eliminator, defective	1
Valve(s), defective	1
Material frayed	1
Kinked	1
Increase in pressure	1
Coagulation in device or device ingredient	1
Restricted flowrate	1
Device remains activated	1
Valve(s), failure of	1
Failure to Adhere or Bond	1
Aspiration issue	1
Foreign material present in device	1
Out-of-box failure	1
Device operates differently than expected	1
Material separation	1
Repair	1
Burst	1
Bent	1
Detachment of device or device component	1
Bacterial contamination of device	1
Device abrasion from instrument or another object	1
Component missing	1
Fluid leak	1
Particulates	1
Premature explantation	1
Defective item	1
Component(s), broken	1
Torn material	1
Material puncture	1
Cut in material	1
Difficult to position	1
Total Device Problems	3226