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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)
2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 4 4 5 1

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 63 888
2024 17 17

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 63 888
Material Rupture 21 21
Difficult to Remove 16 16
Detachment of Device or Device Component 13 13
Insufficient Information 9 9
Difficult to Advance 8 8
Entrapment of Device 8 8
Break 7 7
Material Separation 6 6
Off-Label Use 6 6
Sparking 4 4
Material Split, Cut or Torn 3 3
Material Puncture/Hole 3 3
Failure to Cycle 2 2
Deflation Problem 2 2
Partial Blockage 2 2
Inflation Problem 2 2
Output Problem 2 2
Deformation Due to Compressive Stress 2 2
Use of Device Problem 2 2
Activation Failure 2 2
Material Twisted/Bent 2 2
Material Perforation 1 1
Failure to Advance 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Physical Resistance/Sticking 1 1
Intermittent Energy Output 1 1
Unintended Deflation 1 1
Mechanical Problem 1 1
Decrease in Pressure 1 1
Accessory Incompatible 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Unexpected Therapeutic Results 1 1
Retraction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 36 36
Vascular Dissection 26 522
Perforation 22 847
Cardiac Arrest 21 846
Insufficient Information 16 16
Myocardial Infarction 13 838
Perforation of Vessels 11 11
Cardiac Tamponade 10 835
Arrhythmia 10 296
Pericardial Effusion 9 9
Thrombosis/Thrombus 9 9
Foreign Body In Patient 8 8
Chest Pain 6 6
Pulmonary Edema 6 831
Hematoma 5 5
Low Blood Pressure/ Hypotension 5 5
Cardiogenic Shock 5 91
Ventricular Fibrillation 5 5
Ischemia Stroke 5 744
Angina 4 4
Hemorrhage/Bleeding 4 4
Stroke/CVA 3 3
Bradycardia 3 3
Air Embolism 2 2
Sepsis 2 88
Tachycardia 2 2
Discomfort 2 2
Obstruction/Occlusion 2 2
Low Cardiac Output 2 2
Embolism/Embolus 2 2
Asystole 2 2
Unspecified Tissue Injury 1 1
Restenosis 1 1
Foreign Body Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Cardiac Perforation 1 1
Electric Shock 1 1
Thromboembolism 1 1
Low Oxygen Saturation 1 1
Device Embedded In Tissue or Plaque 1 1
Ventilator Dependent 1 1
Nausea 1 1
Ischemia 1 1
Laceration(s) 1 1
Abdominal Pain 1 1
Non specific EKG/ECG Changes 1 1
Extravasation 1 1

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