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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	23	23
Detachment of Device or Device Component	14	14
Power Problem	11	11
Material Split, Cut or Torn	5	5
Material Deformation	5	5
Material Separation	5	5
Break	4	4
Failure to Calibrate	3	3
Material Integrity Problem	2	2
Material Frayed	2	2
Energy Output Problem	1	1
Material Puncture/Hole	1	1
Failure to Recalibrate	1	1
Crack	1	1
Failure to Deliver Energy	1	123
Fracture	1	1
Material Fragmentation	1	1
Material Twisted/Bent	1	1
Device Dislodged or Dislocated	1	1
Device Displays Incorrect Message	1	1
Calibration Problem	1	1
Therapeutic or Diagnostic Output Failure	1	1
Insufficient Information	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	22	144
Perforation of Vessels	19	19
Thrombosis/Thrombus	14	14
Iatrogenic Source	12	12
Radiation Exposure, Unintended	9	9
Unintended Radiation Exposure	6	6
No Consequences Or Impact To Patient	5	5
Device Embedded In Tissue or Plaque	3	3
Cardiac Perforation	3	3
No Known Impact Or Consequence To Patient	3	3
Death	2	2
Perforation	2	2
Insufficient Information	2	2
Chest Pain	1	1
Cardiac Tamponade	1	1
Shock	1	1
Low Blood Pressure/ Hypotension	1	1
Vascular Dissection	1	1