TPLC - Total Product Life Cycle

show TPLC since

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

Premarket Approvals (PMA)
2009	2010	2011	2012	2013	2014	2015	2016	2017	2018	2019	2020	2021	2022	2023	2024
3	4	10	11	5	7	7	7	10	8	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	42	42
Insufficient Information	25	25
Detachment of Device or Device Component	15	15
Power Problem	11	11
Break	7	7
Material Separation	7	7
Material Deformation	6	6
Material Split, Cut or Torn	5	5
Device Displays Incorrect Message	4	4
Failure to Calibrate	4	4
Device Operates Differently Than Expected	4	4
Device Dislodged or Dislocated	4	4
Detachment Of Device Component	3	3
Difficult to Advance	3	3
Difficult to Remove	3	3
Material Protrusion/Extrusion	2	2
Calibration Problem	2	2
Material Frayed	2	2
Leak/Splash	2	2
Material Integrity Problem	2	2
Incorrect Or Inadequate Test Results	2	2
Occlusion Within Device	2	2
Component Falling	1	1
Improper or Incorrect Procedure or Method	1	1
Device Inoperable	1	1
Failure to Cycle	1	1
Solder Joint Fracture	1	1
Inflation Problem	1	1
Physical Resistance	1	1
Thermal Decomposition of Device	1	1
Material Perforation	1	1
Material Twisted/Bent	1	1
Obstruction of Flow	1	1
Use of Device Problem	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Therapeutic or Diagnostic Output Failure	1	1
Failure to Recalibrate	1	1
Defective Device	1	1
Positioning Problem	1	1
Crack	1	1
Failure to Deliver Energy	1	123
Pressure Problem	1	1
Failure to Advance	1	1
Fracture	1	1
Failure to Fire	1	1
Sticking	1	1
Device Contamination with Chemical or Other Material	1	1
Material Puncture/Hole	1	1
Energy Output Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation	37	37
Perforation of Vessels	28	28
No Clinical Signs, Symptoms or Conditions	23	145
Iatrogenic Source	18	18
No Known Impact Or Consequence To Patient	15	15
Thrombosis/Thrombus	14	14
Radiation Exposure, Unintended	9	9
Death	8	8
No Consequences Or Impact To Patient	8	8
Vascular Dissection	7	7
Device Embedded In Tissue or Plaque	7	7
Unintended Radiation Exposure	7	7
Cardiac Perforation	6	6
Hemorrhage/Bleeding	6	6
Low Blood Pressure/ Hypotension	4	4
Cardiac Tamponade	3	3
Injury	3	3
Stenosis	3	3
Intimal Dissection	3	3
No Code Available	2	2
Obstruction/Occlusion	2	2
Insufficient Information	2	2
No Information	1	1
Occlusion	1	1
Cardiac Arrest	1	1
Visual Disturbances	1	1
Foreign Body In Patient	1	1
Angina	1	1
Chest Pain	1	1
Hemostasis	1	1
Pain	1	1
Extravasation	1	1
Shock	1	1
Embolism	1	1
Pseudoaneurysm	1	1
Aneurysm	1	1
Atrial Perforation	1	1