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
Material Separation	7	7
Break	7	7
Material Deformation	6	6
Material Split, Cut or Torn	5	5
Device Dislodged or Dislocated	4	4
Failure to Calibrate	4	4
Device Operates Differently Than Expected	4	4
Device Displays Incorrect Message	4	4
Detachment Of Device Component	3	3
Difficult to Advance	3	3
Difficult to Remove	3	3
Material Protrusion/Extrusion	2	2
Material Integrity Problem	2	2
Calibration Problem	2	2
Occlusion Within Device	2	2
Incorrect Or Inadequate Test Results	2	2
Leak/Splash	2	2
Material Frayed	2	2
Solder Joint Fracture	1	1
Use of Device Problem	1	1
Inflation Problem	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Recalibrate	1	1
Therapeutic or Diagnostic Output Failure	1	1
Defective Device	1	1
Obstruction of Flow	1	1
Positioning Problem	1	1
Material Twisted/Bent	1	1
Failure to Advance	1	1
Fracture	1	1
Material Puncture/Hole	1	1
Energy Output Problem	1	1
Failure to Cycle	1	1
Device Inoperable	1	1
Mechanical Problem	1	1
Unintended Movement	1	1
Output Problem	1	1
Material Fragmentation	1	1
Difficult to Insert	1	1
Physical Resistance	1	1
Crack	1	1
Thermal Decomposition of Device	1	1
Material Perforation	1	1
Sticking	1	1
Pressure Problem	1	1
Failure to Deliver Energy	1	123

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
Occlusion	1	1
No Information	1	1
Cardiac Arrest	1	1
Angina	1	1
Visual Disturbances	1	1
Foreign Body In Patient	1	1
Chest Pain	1	1
Hemostasis	1	1
Pain	1	1
Extravasation	1	1
Shock	1	1
Aneurysm	1	1
Embolism	1	1
Pseudoaneurysm	1	1
Atrial Perforation	1	1