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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shockwave intravascular lithotripsy system
Definition Dilatation of coronary arteries prior to stenting
Product CodeQMG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
4 4 5 2 4 3

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 63 889
2024 113 113
2025 130 130
2026 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 204 1030
Material Split, Cut or Torn 50 50
Difficult to Remove 32 32
Detachment of Device or Device Component 31 31
Material Rupture 27 27
Difficult to Advance 21 21
Off-Label Use 16 16
Insufficient Information 12 12
Entrapment of Device 9 9
Break 9 9
Failure to Deflate 7 7
Sparking 6 6
Failure to Cycle 6 6
Material Separation 6 6
Inflation Problem 5 5
Material Puncture/Hole 4 4
Deflation Problem 4 4
Deformation Due to Compressive Stress 3 3
No Apparent Adverse Event 3 3
Material Twisted/Bent 2 2
Activation Failure 2 2
Difficult or Delayed Positioning 2 2
Partial Blockage 2 2
Use of Device Problem 2 2
Failure to Advance 2 2
Output Problem 2 2
Packaging Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Separation Failure 1 1
Defective Device 1 1
Device Displays Incorrect Message 1 1
Material Perforation 1 1
Unexpected Therapeutic Results 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Crack 1 1
Retraction Problem 1 1
Mechanical Problem 1 1
Decrease in Pressure 1 1
Unintended Deflation 1 1
Physical Resistance/Sticking 1 1
Unexpected Shutdown 1 1
Intermittent Energy Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Myocardial Infarction 82 907
No Clinical Signs, Symptoms or Conditions 73 73
Vascular Dissection 59 555
Cardiac Arrest 49 874
Perforation of Vessels 46 46
Chest Pain 39 39
Perforation 27 852
Insufficient Information 27 27
Pericardial Effusion 26 26
Thrombosis/Thrombus 23 23
Low Blood Pressure/ Hypotension 22 22
Arrhythmia 21 308
Ventricular Fibrillation 20 20
Cardiac Tamponade 19 844
Foreign Body In Patient 16 16
Obstruction/Occlusion 15 15
Hematoma 13 13
Bradycardia 10 10
Non specific EKG/ECG Changes 7 7
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
Air Embolism 4 4
Stroke/CVA 4 4
Asystole 4 4
Thromboembolism 3 3
Sepsis 3 89
Cardiac Enzyme Elevation 3 3
Restenosis 2 2
Aspiration Pneumonitis 2 2
Pseudoaneurysm 2 2
Shock 2 2
Discomfort 2 2
Low Cardiac Output 2 2
Ischemia 2 2
High Blood Pressure/ Hypertension 2 2
Abdominal Pain 2 2
Laceration(s) 1 1
Foreign Body Embolism 1 1
Heart Failure/Congestive Heart Failure 1 1
Calcium Deposits/Calcification 1 1
Extravasation 1 1
Septic Shock 1 1
Cardiac Perforation 1 1
Pericarditis 1 1

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