TPLC - Total Product Life Cycle

show TPLC since

Device	device, angioplasty, laser, coronary
Product Code	LPC
Device Class	3

Premarket Approvals (PMA)
2021	2022	2023	2024	2025	2026
2	4	4	2	1	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Power Problem	13	13
Material Separation	10	10
Detachment of Device or Device Component	6	6
Sharp Edges	4	4
Break	3	3
Entrapment of Device	3	3
Off-Label Use	3	3
Failure to Align	3	3
Failure to Calibrate	3	3
Energy Output Problem	2	2
Melted	2	2
Failure to Deliver Energy	1	123
Material Frayed	1	1
Activation, Positioning or Separation Problem	1	1
Material Split, Cut or Torn	1	1
Material Puncture/Hole	1	1
Failure to Recalibrate	1	1
Therapeutic or Diagnostic Output Failure	1	1
Material Twisted/Bent	1	1
Calibration Problem	1	1
Material Deformation	1	1
Complete Loss of Power	1	1
Device Displays Incorrect Message	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	42	164
Perforation of Vessels	20	20
Thrombosis/Thrombus	14	14
Unintended Radiation Exposure	8	8
Iatrogenic Source	2	2
Insufficient Information	2	2
Cardiac Perforation	1	1
Foreign Body In Patient	1	1
Device Embedded In Tissue or Plaque	1	1