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TPLC
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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)
2021
2022
2023
2024
2025
2026
4
4
5
2
4
0
MDR Year
MDR Reports
MDR Events
2021
21
21
2022
57
57
2023
63
889
2024
113
113
2025
130
130
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
196
1022
Material Split, Cut or Torn
42
42
Detachment of Device or Device Component
27
27
Difficult to Remove
26
26
Material Rupture
24
24
Difficult to Advance
20
20
Off-Label Use
13
13
Insufficient Information
12
12
Break
8
8
Entrapment of Device
8
8
Material Separation
6
6
Failure to Deflate
5
5
Failure to Cycle
5
5
Sparking
4
4
Material Puncture/Hole
4
4
Deformation Due to Compressive Stress
3
3
No Apparent Adverse Event
3
3
Deflation Problem
3
3
Failure to Advance
2
2
Activation Failure
2
2
Partial Blockage
2
2
Inflation Problem
2
2
Difficult or Delayed Positioning
2
2
Material Twisted/Bent
2
2
Use of Device Problem
2
2
Output Problem
2
2
Gas/Air Leak
1
1
Decrease in Pressure
1
1
Material Perforation
1
1
Therapeutic or Diagnostic Output Failure
1
1
Defective Device
1
1
Unintended Deflation
1
1
Material Deformation
1
1
Packaging Problem
1
1
Unintended Movement
1
1
Retraction Problem
1
1
Separation Failure
1
1
Collapse
1
1
Intermittent Energy Output
1
1
Accessory Incompatible
1
1
Physical Resistance/Sticking
1
1
Unexpected Therapeutic Results
1
1
Mechanical Problem
1
1
Burst Container or Vessel
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Myocardial Infarction
76
901
No Clinical Signs, Symptoms or Conditions
64
64
Vascular Dissection
57
553
Cardiac Arrest
48
873
Perforation of Vessels
40
40
Chest Pain
35
35
Perforation
27
852
Insufficient Information
26
26
Pericardial Effusion
25
25
Thrombosis/Thrombus
23
23
Arrhythmia
20
307
Ventricular Fibrillation
19
19
Cardiac Tamponade
18
843
Low Blood Pressure/ Hypotension
17
17
Foreign Body In Patient
14
14
Hematoma
13
13
Obstruction/Occlusion
13
13
Bradycardia
10
10
Hemorrhage/Bleeding
6
6
Embolism/Embolus
6
6
Pulmonary Edema
6
831
Cardiogenic Shock
6
92
Ischemia Stroke
5
744
Atrial Fibrillation
5
5
Tachycardia
5
5
Angina
5
5
Non specific EKG/ECG Changes
4
4
Stroke/CVA
4
4
Asystole
4
4
Air Embolism
3
3
Thromboembolism
3
3
Sepsis
3
89
Restenosis
2
2
Aspiration Pneumonitis
2
2
Pseudoaneurysm
2
2
Shock
2
2
Discomfort
2
2
Low Cardiac Output
2
2
Ischemia
2
2
Abdominal Pain
2
2
Foreign Body Embolism
1
1
Laceration(s)
1
1
Septic Shock
1
1
Heart Failure/Congestive Heart Failure
1
1
Calcium Deposits/Calcification
1
1
Extravasation
1
1
Cardiac Perforation
1
1
Pericarditis
1
1
Cellulitis
1
1
Unspecified Tissue Injury
1
1
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