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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 2

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 63 889
2024 113 113
2025 130 130
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 201 1027
Material Split, Cut or Torn 46 46
Difficult to Remove 30 30
Detachment of Device or Device Component 28 28
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
Failure to Deflate 6 6
Material Separation 6 6
Sparking 5 5
Failure to Cycle 5 5
Material Puncture/Hole 4 4
Inflation Problem 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
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
Unintended Movement 1 1
Material Deformation 1 1
Packaging Problem 1 1
Separation Failure 1 1
Retraction Problem 1 1
Collapse 1 1
Intermittent Energy Output 1 1
Crack 1 1
Accessory Incompatible 1 1
Physical Resistance/Sticking 1 1
Unexpected Therapeutic Results 1 1
Mechanical Problem 1 1
Device Displays Incorrect Message 1 1
Burst Container or Vessel 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Myocardial Infarction 78 903
No Clinical Signs, Symptoms or Conditions 67 67
Vascular Dissection 57 553
Cardiac Arrest 49 874
Perforation of Vessels 44 44
Chest Pain 36 36
Perforation 27 852
Insufficient Information 26 26
Pericardial Effusion 25 25
Thrombosis/Thrombus 23 23
Arrhythmia 20 307
Low Blood Pressure/ Hypotension 19 19
Ventricular Fibrillation 19 19
Cardiac Tamponade 18 843
Foreign Body In Patient 15 15
Obstruction/Occlusion 14 14
Hematoma 13 13
Bradycardia 10 10
Hemorrhage/Bleeding 6 6
Embolism/Embolus 6 6
Pulmonary Edema 6 831
Cardiogenic Shock 6 92
Non specific EKG/ECG Changes 5 5
Ischemia Stroke 5 744
Atrial Fibrillation 5 5
Tachycardia 5 5
Angina 5 5
Stroke/CVA 4 4
Asystole 4 4
Air Embolism 3 3
Thromboembolism 3 3
Sepsis 3 89
Aspiration Pneumonitis 2 2
Restenosis 2 2
Pseudoaneurysm 2 2
Shock 2 2
Discomfort 2 2
Low Cardiac Output 2 2
Ischemia 2 2
Abdominal Pain 2 2
Septic Shock 1 1
Laceration(s) 1 1
Foreign Body Embolism 1 1
Heart Failure/Congestive Heart Failure 1 1
Cardiac Perforation 1 1
Pericarditis 1 1
Unspecified Tissue Injury 1 1
Cellulitis 1 1
Extravasation 1 1
Calcium Deposits/Calcification 1 1

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