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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 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 81 81

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 100 925
Material Rupture 21 21
Difficult to Remove 18 18
Detachment of Device or Device Component 17 17
Material Split, Cut or Torn 17 17
Difficult to Advance 10 10
Insufficient Information 10 10
Entrapment of Device 8 8
Break 7 7
Off-Label Use 7 7
Material Separation 6 6
Sparking 4 4
Material Puncture/Hole 3 3
Partial Blockage 2 2
Activation Failure 2 2
Deformation Due to Compressive Stress 2 2
Output Problem 2 2
Failure to Cycle 2 2
Deflation Problem 2 2
Material Twisted/Bent 2 2
Use of Device Problem 2 2
Inflation Problem 2 2
No Apparent Adverse Event 1 1
Retraction Problem 1 1
Burst Container or Vessel 1 1
Mechanical Problem 1 1
Physical Resistance/Sticking 1 1
Material Perforation 1 1
Decrease in Pressure 1 1
Failure to Advance 1 1
Unexpected Therapeutic Results 1 1
Accessory Incompatible 1 1
Intermittent Energy Output 1 1
Unintended Movement 1 1
Unintended Deflation 1 1
Collapse 1 1
Gas/Air Leak 1 1
Material Deformation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Vascular Dissection 36 532
Cardiac Arrest 29 854
Perforation 23 848
Myocardial Infarction 21 846
Insufficient Information 20 20
Perforation of Vessels 19 19
Pericardial Effusion 16 16
Thrombosis/Thrombus 15 15
Chest Pain 14 14
Cardiac Tamponade 13 838
Arrhythmia 11 297
Hematoma 10 10
Low Blood Pressure/ Hypotension 9 9
Ventricular Fibrillation 9 9
Foreign Body In Patient 8 8
Obstruction/Occlusion 6 6
Cardiogenic Shock 6 92
Pulmonary Edema 6 831
Hemorrhage/Bleeding 6 6
Bradycardia 5 5
Ischemia Stroke 5 744
Atrial Fibrillation 4 4
Embolism/Embolus 4 4
Angina 4 4
Stroke/CVA 4 4
Asystole 4 4
Tachycardia 3 3
Low Cardiac Output 2 2
Sepsis 2 88
Air Embolism 2 2
Discomfort 2 2
Pseudoaneurysm 2 2
Thromboembolism 2 2
Ischemia 1 1
Anemia 1 1
Nausea 1 1
Cellulitis 1 1
Electric Shock 1 1
Cardiac Perforation 1 1
Foreign Body Embolism 1 1
High Blood Pressure/ Hypertension 1 1
Septic Shock 1 1
Laceration(s) 1 1
Heart Failure/Congestive Heart Failure 1 1
Abdominal Pain 1 1
Unspecified Tissue Injury 1 1
Extravasation 1 1
Calcium Deposits/Calcification 1 1
Swelling/ Edema 1 1

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