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	1

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	84	84
Material Separation	17	17
Power Problem	13	13
Detachment of Device or Device Component	6	6
Energy Output Problem	5	5
Sharp Edges	5	5
Off-Label Use	3	3
Failure to Align	3	3
Break	3	3
Entrapment of Device	3	3
Complete Loss of Power	2	2
Melted	2	2
Failure to Recalibrate	1	1
Failure to Calibrate	1	1
Material Frayed	1	1
Failure to Power Up	1	1
Material Twisted/Bent	1	1
Material Protrusion/Extrusion	1	1
Connection Problem	1	1
Failure to Deliver Energy	1	123
Calibration Problem	1	1
Material Deformation	1	1
Material Puncture/Hole	1	1
Material Split, Cut or Torn	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
No Clinical Signs, Symptoms or Conditions	51	173
Perforation of Vessels	38	38
Obstruction/Occlusion	23	23
Thrombosis/Thrombus	22	22
Vascular Dissection	16	16
Myocardial Infarction	14	14
Unintended Radiation Exposure	13	13
Insufficient Information	9	9
Embolism/Embolus	6	6
Unspecified Heart Problem	6	6
Cardiac Tamponade	4	4
Restenosis	3	3
Cardiogenic Shock	3	3
Angina	2	2
Iatrogenic Source	2	2
Cardiac Perforation	2	2
Hemorrhage/Blood Loss/Bleeding	1	1
Bradycardia	1	1
Unspecified Vascular Problem	1	1
Heart Failure/Congestive Heart Failure	1	1
Low Blood Pressure/ Hypotension	1	1
Stroke/CVA	1	1
Device Embedded In Tissue or Plaque	1	1
Ischemia Stroke	1	1
Transient Ischemic Attack	1	1
Shock	1	1
Aneurysm	1	1
Ulcer	1	1
Atrial Fibrillation	1	1
Foreign Body In Patient	1	1
Cardiac Arrest	1	1
Tachycardia	1	1
Ventricular Fibrillation	1	1
Gastrointestinal Hemorrhage	1	1