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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)
2018 2019 2020 2021 2022 2023
0 0 0 4 4 5

MDR Year MDR Reports MDR Events
2021 21 21
2022 57 57
2023 37 862

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 48 873
Material Rupture 17 17
Difficult to Remove 12 12
Detachment of Device or Device Component 11 11
Insufficient Information 9 9
Break 7 7
Entrapment of Device 7 7
Off-Label Use 4 4
Sparking 4 4
Difficult to Advance 4 4
Material Separation 3 3
Deflation Problem 2 2
Use of Device Problem 2 2
Inflation Problem 2 2
Activation Failure 2 2
Output Problem 2 2
Material Twisted/Bent 2 2
No Apparent Adverse Event 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Intermittent Energy Output 1 1
Unintended Deflation 1 1
Gas/Air Leak 1 1
Material Deformation 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Burst Container or Vessel 1 1
Collapse 1 1
Accessory Incompatible 1 1
Partial Blockage 1 1
Failure to Advance 1 1
Deformation Due to Compressive Stress 1 1
Unexpected Therapeutic Results 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Vascular Dissection 22 518
No Clinical Signs, Symptoms or Conditions 22 22
Perforation 19 844
Cardiac Arrest 16 841
Insufficient Information 15 15
Myocardial Infarction 12 837
Cardiac Tamponade 7 832
Foreign Body In Patient 6 6
Arrhythmia 6 292
Pulmonary Edema 6 831
Pericardial Effusion 6 6
Ischemia Stroke 5 744
Thrombosis/Thrombus 5 5
Perforation of Vessels 5 5
Ventricular Fibrillation 4 4
Cardiogenic Shock 4 90
Low Blood Pressure/ Hypotension 4 4
Chest Pain 4 4
Stroke/CVA 3 3
Angina 3 3
Hemorrhage/Bleeding 3 3
Hematoma 2 2
Sepsis 2 88
Tachycardia 2 2
Bradycardia 2 2
Asystole 2 2
Unspecified Tissue Injury 1 1
Restenosis 1 1
Embolism/Embolus 1 1
Foreign Body Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Abdominal Pain 1 1
Air Embolism 1 1
Non specific EKG/ECG Changes 1 1
Extravasation 1 1
Ischemia 1 1
Nausea 1 1
Device Embedded In Tissue or Plaque 1 1
Discomfort 1 1
Ventilator Dependent 1 1
Obstruction/Occlusion 1 1
Low Oxygen Saturation 1 1
Cardiac Perforation 1 1
Electric Shock 1 1

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