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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 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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