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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 39 39

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 210 1036
Material Split, Cut or Torn 51 51
Detachment of Device or Device Component 32 32
Difficult to Remove 32 32
Material Rupture 27 27
Difficult to Advance 22 22
Off-Label Use 16 16
Insufficient Information 12 12
Break 9 9
Entrapment of Device 9 9
Failure to Deflate 7 7
Failure to Cycle 6 6
Material Separation 6 6
Sparking 6 6
Inflation Problem 5 5
Material Puncture/Hole 4 4
Deflation Problem 4 4
Deformation Due to Compressive Stress 4 4
No Apparent Adverse Event 3 3
Use of Device Problem 2 2
Material Twisted/Bent 2 2
Difficult or Delayed Positioning 2 2
Output Problem 2 2
Partial Blockage 2 2
Activation Failure 2 2
Failure to Advance 2 2
Collapse 1 1
Separation Failure 1 1
Intermittent Energy Output 1 1
Unintended Movement 1 1
Crack 1 1
Unintended Deflation 1 1
Defective Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Accessory Incompatible 1 1
Gas/Air Leak 1 1
Decrease in Pressure 1 1
Material Perforation 1 1
Physical Resistance/Sticking 1 1
Material Deformation 1 1
Packaging Problem 1 1
Retraction Problem 1 1
Mechanical Problem 1 1
Burst Container or Vessel 1 1
Unexpected Shutdown 1 1
Unexpected Therapeutic Results 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Myocardial Infarction 86 911
No Clinical Signs, Symptoms or Conditions 74 74
Vascular Dissection 66 562
Cardiac Arrest 49 874
Perforation of Vessels 49 49
Chest Pain 42 42
Perforation 28 853
Insufficient Information 27 27
Pericardial Effusion 26 26
Thrombosis/Thrombus 23 23
Low Blood Pressure/ Hypotension 22 22
Arrhythmia 21 308
Cardiac Tamponade 20 845
Ventricular Fibrillation 20 20
Obstruction/Occlusion 16 16
Foreign Body In Patient 16 16
Hematoma 13 13
Bradycardia 10 10
Non specific EKG/ECG Changes 7 7
Hemorrhage/Bleeding 7 7
Embolism/Embolus 6 6
Pulmonary Edema 6 831
Cardiogenic Shock 6 92
Ischemia Stroke 5 744
Cardiac Enzyme Elevation 5 5
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
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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