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	0

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	41	41
Insufficient Information	25	25
Detachment of Device or Device Component	15	15
Power Problem	10	10
Break	7	7
Material Deformation	6	6
Material Separation	6	6
Material Split, Cut or Torn	5	5
Device Dislodged or Dislocated	4	4
Failure to Calibrate	4	4
Device Displays Incorrect Message	4	4
Device Operates Differently Than Expected	4	4
Difficult to Remove	3	3
Detachment Of Device Component	3	3
Difficult to Advance	3	3
Incorrect Or Inadequate Test Results	2	2
Calibration Problem	2	2
Leak/Splash	2	2
Material Protrusion/Extrusion	2	2
Material Integrity Problem	2	2
Occlusion Within Device	2	2
Material Frayed	2	2
Material Puncture/Hole	1	1
Use of Device Problem	1	1
Failure to Recalibrate	1	1
Therapeutic or Diagnostic Output Failure	1	1
Obstruction of Flow	1	1
Improper or Incorrect Procedure or Method	1	1
Failure to Fire	1	1
Solder Joint Fracture	1	1
Failure to Advance	1	1
Device Inoperable	1	1
Energy Output Problem	1	1
Fracture	1	1
Material Twisted/Bent	1	1
Physical Resistance	1	1
Inflation Problem	1	1
Failure to Cycle	1	1
Failure to Deliver Energy	1	123
Material Fragmentation	1	1
Device Contamination with Chemical or Other Material	1	1
Unintended Movement	1	1
Pressure Problem	1	1
Sticking	1	1
Material Perforation	1	1
Defective Device	1	1
Mechanical Problem	1	1
Crack	1	1
Output Problem	1	1
Difficult to Insert	1	1
Positioning Problem	1	1
Thermal Decomposition of Device	1	1
Component Falling	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Perforation	37	37
Perforation of Vessels	27	27
No Clinical Signs, Symptoms or Conditions	21	143
Iatrogenic Source	18	18
No Known Impact Or Consequence To Patient	15	15
Thrombosis/Thrombus	14	14
Radiation Exposure, Unintended	9	9
No Consequences Or Impact To Patient	8	8
Death	8	8
Device Embedded In Tissue or Plaque	7	7
Vascular Dissection	7	7
Cardiac Perforation	6	6
Unintended Radiation Exposure	6	6
Hemorrhage/Bleeding	6	6
Low Blood Pressure/ Hypotension	4	4
Cardiac Tamponade	3	3
Stenosis	3	3
Injury	3	3
Intimal Dissection	3	3
Obstruction/Occlusion	2	2
Insufficient Information	2	2
No Code Available	2	2
No Information	1	1
Pseudoaneurysm	1	1
Foreign Body In Patient	1	1
Atrial Perforation	1	1
Visual Disturbances	1	1
Occlusion	1	1
Pain	1	1
Shock	1	1
Aneurysm	1	1
Angina	1	1
Cardiac Arrest	1	1
Chest Pain	1	1
Hemostasis	1	1
Embolism	1	1
Extravasation	1	1