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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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New Search show TPLC since Back to Search Results
Device shockwave intravascular lithotripsy system
Definition Dilatation of coronary arteries prior to stenting
Product CodeQMG
Device Class 3

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
0 0 0 0 4 3

MDR Year MDR Reports MDR Events
2021 21 21
2022 51 51

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 28 28
Material Rupture 9 9
Insufficient Information 8 8
Detachment of Device or Device Component 6 6
Break 6 6
Difficult to Remove 6 6
Entrapment of Device 5 5
Sparking 4 4
Difficult to Advance 3 3
Material Separation 3 3
Use of Device Problem 2 2
Deflation Problem 2 2
Off-Label Use 2 2
Output Problem 2 2
No Apparent Adverse Event 1 1
Deformation Due to Compressive Stress 1 1
Activation Failure 1 1
Material Split, Cut or Torn 1 1
Physical Resistance/Sticking 1 1
Unintended Deflation 1 1
Material Puncture/Hole 1 1
Inflation Problem 1 1
Decrease in Pressure 1 1
Burst Container or Vessel 1 1
Failure to Advance 1 1
Unexpected Therapeutic Results 1 1
Material Deformation 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 14 14
No Clinical Signs, Symptoms or Conditions 13 13
Vascular Dissection 10 10
Cardiac Arrest 7 7
Myocardial Infarction 6 6
Perforation of Vessels 5 5
Thrombosis/Thrombus 5 5
Foreign Body In Patient 4 4
Arrhythmia 4 4
Stroke/CVA 3 3
Angina 2 2
Perforation 2 2
Ventricular Fibrillation 2 2
Hematoma 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Cardiogenic Shock 2 2
Asystole 2 2
Pericardial Effusion 2 2
Embolism/Embolus 1 1
Foreign Body Embolism 1 1
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 1 1
Discomfort 1 1
Ventilator Dependent 1 1
Obstruction/Occlusion 1 1
Cardiac Perforation 1 1
Electric Shock 1 1
Sepsis 1 1
Tachycardia 1 1
Chest Pain 1 1

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