TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2019	2020	2021	2022	2023	2024
2	1	2	4	4	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	24	24
Detachment of Device or Device Component	14	14
Power Problem	11	11
Material Separation	6	6
Material Deformation	5	5
Material Split, Cut or Torn	5	5
Break	4	4
Failure to Calibrate	3	3
Material Integrity Problem	2	2
Material Frayed	2	2
Crack	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Recalibrate	1	1
Material Fragmentation	1	1
Material Twisted/Bent	1	1
Calibration Problem	1	1
Device Displays Incorrect Message	1	1
Failure to Deliver Energy	1	123
Energy Output Problem	1	1
Material Puncture/Hole	1	1
Insufficient Information	1	1
Fracture	1	1
Device Dislodged or Dislocated	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	23	145
Perforation of Vessels	20	20
Thrombosis/Thrombus	14	14
Iatrogenic Source	12	12
Radiation Exposure, Unintended	9	9
Unintended Radiation Exposure	7	7
No Consequences Or Impact To Patient	5	5
No Known Impact Or Consequence To Patient	3	3
Cardiac Perforation	3	3
Device Embedded In Tissue or Plaque	3	3
Death	2	2
Perforation	2	2
Insufficient Information	2	2
Vascular Dissection	1	1
Cardiac Tamponade	1	1
Chest Pain	1	1
Shock	1	1
Low Blood Pressure/ Hypotension	1	1