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TPLC
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show TPLC since
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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)
2016
2017
2018
2019
2020
2021
2022
2023
2024
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
17
17
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
63
888
Material Rupture
21
21
Difficult to Remove
16
16
Detachment of Device or Device Component
13
13
Insufficient Information
9
9
Difficult to Advance
8
8
Entrapment of Device
8
8
Break
7
7
Material Separation
6
6
Off-Label Use
6
6
Sparking
4
4
Material Split, Cut or Torn
3
3
Material Puncture/Hole
3
3
Failure to Cycle
2
2
Deflation Problem
2
2
Partial Blockage
2
2
Inflation Problem
2
2
Output Problem
2
2
Deformation Due to Compressive Stress
2
2
Use of Device Problem
2
2
Activation Failure
2
2
Material Twisted/Bent
2
2
Material Perforation
1
1
Failure to Advance
1
1
Gas/Air Leak
1
1
Material Deformation
1
1
Unintended Movement
1
1
No Apparent Adverse Event
1
1
Physical Resistance/Sticking
1
1
Intermittent Energy Output
1
1
Unintended Deflation
1
1
Mechanical Problem
1
1
Decrease in Pressure
1
1
Accessory Incompatible
1
1
Burst Container or Vessel
1
1
Collapse
1
1
Unexpected Therapeutic Results
1
1
Retraction Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
36
36
Vascular Dissection
26
522
Perforation
22
847
Cardiac Arrest
21
846
Insufficient Information
16
16
Myocardial Infarction
13
838
Perforation of Vessels
11
11
Cardiac Tamponade
10
835
Arrhythmia
10
296
Pericardial Effusion
9
9
Thrombosis/Thrombus
9
9
Foreign Body In Patient
8
8
Chest Pain
6
6
Pulmonary Edema
6
831
Hematoma
5
5
Low Blood Pressure/ Hypotension
5
5
Cardiogenic Shock
5
91
Ventricular Fibrillation
5
5
Ischemia Stroke
5
744
Angina
4
4
Hemorrhage/Bleeding
4
4
Stroke/CVA
3
3
Bradycardia
3
3
Air Embolism
2
2
Sepsis
2
88
Tachycardia
2
2
Discomfort
2
2
Obstruction/Occlusion
2
2
Low Cardiac Output
2
2
Embolism/Embolus
2
2
Asystole
2
2
Unspecified Tissue Injury
1
1
Restenosis
1
1
Foreign Body Embolism
1
1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
Cardiac Perforation
1
1
Electric Shock
1
1
Thromboembolism
1
1
Low Oxygen Saturation
1
1
Device Embedded In Tissue or Plaque
1
1
Ventilator Dependent
1
1
Nausea
1
1
Ischemia
1
1
Laceration(s)
1
1
Abdominal Pain
1
1
Non specific EKG/ECG Changes
1
1
Extravasation
1
1
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