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TPLC - Total Product Life Cycle
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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
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2018
2019
2020
2021
2022
2023
2024
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Device
shockwave intravascular lithotripsy system
Definition
Dilatation of coronary arteries prior to stenting
Product Code
QMG
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
0
0
0
0
0
4
4
5
1
MDR Year
MDR Reports
MDR Events
2021
21
21
2022
57
57
2023
63
888
2024
81
81
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
100
925
Material Rupture
21
21
Difficult to Remove
18
18
Material Split, Cut or Torn
17
17
Detachment of Device or Device Component
17
17
Insufficient Information
10
10
Difficult to Advance
10
10
Entrapment of Device
8
8
Off-Label Use
7
7
Break
7
7
Material Separation
6
6
Sparking
4
4
Material Puncture/Hole
3
3
Output Problem
2
2
Inflation Problem
2
2
Deflation Problem
2
2
Material Twisted/Bent
2
2
Use of Device Problem
2
2
Activation Failure
2
2
Partial Blockage
2
2
Failure to Cycle
2
2
Deformation Due to Compressive Stress
2
2
Accessory Incompatible
1
1
Intermittent Energy Output
1
1
Unintended Movement
1
1
Collapse
1
1
Unintended Deflation
1
1
Mechanical Problem
1
1
Burst Container or Vessel
1
1
Physical Resistance/Sticking
1
1
Material Deformation
1
1
Gas/Air Leak
1
1
Material Perforation
1
1
Decrease in Pressure
1
1
Retraction Problem
1
1
No Apparent Adverse Event
1
1
Failure to Advance
1
1
Unexpected Therapeutic Results
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
41
41
Vascular Dissection
36
532
Cardiac Arrest
29
854
Perforation
23
848
Myocardial Infarction
21
846
Insufficient Information
20
20
Perforation of Vessels
19
19
Pericardial Effusion
16
16
Thrombosis/Thrombus
15
15
Chest Pain
14
14
Cardiac Tamponade
13
838
Arrhythmia
11
297
Hematoma
10
10
Low Blood Pressure/ Hypotension
9
9
Ventricular Fibrillation
9
9
Foreign Body In Patient
8
8
Obstruction/Occlusion
6
6
Cardiogenic Shock
6
92
Pulmonary Edema
6
831
Hemorrhage/Bleeding
6
6
Bradycardia
5
5
Ischemia Stroke
5
744
Atrial Fibrillation
4
4
Embolism/Embolus
4
4
Angina
4
4
Stroke/CVA
4
4
Asystole
4
4
Tachycardia
3
3
Low Cardiac Output
2
2
Sepsis
2
88
Air Embolism
2
2
Discomfort
2
2
Pseudoaneurysm
2
2
Thromboembolism
2
2
Ischemia
1
1
Anemia
1
1
Nausea
1
1
Cellulitis
1
1
Electric Shock
1
1
Cardiac Perforation
1
1
Foreign Body Embolism
1
1
High Blood Pressure/ Hypertension
1
1
Septic Shock
1
1
Laceration(s)
1
1
Heart Failure/Congestive Heart Failure
1
1
Abdominal Pain
1
1
Unspecified Tissue Injury
1
1
Extravasation
1
1
Calcium Deposits/Calcification
1
1
Swelling/ Edema
1
1
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