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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device percutaneously delivered prostheses and tricuspid valves
Definition These devices are intended to replace a patient's tricuspid heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPW
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 10 4

MDR Year MDR Reports MDR Events
2024 133 133
2025 147 147

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 167 167
Malposition of Device 44 44
Migration 35 35
Difficult to Insert 15 15
Central Regurgitation 14 14
Perivalvular Leak 10 10
Device-Device Incompatibility 9 9
Difficult to Remove 4 4
Activation, Positioning or Separation Problem 3 3
Material Integrity Problem 3 3
Particulates 3 3
Detachment of Device or Device Component 3 3
Defective Component 2 2
Mechanical Problem 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Gradient Increase 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Heart Block 118 118
Failure of Implant 37 37
Thrombosis/Thrombus 22 22
Bradycardia 19 19
No Clinical Signs, Symptoms or Conditions 16 16
Cardiac Perforation 16 16
Insufficient Information 15 15
Arrhythmia 13 13
Heart Failure/Congestive Heart Failure 12 12
Perforation of Vessels 10 10
Hemolysis 5 5
Cardiac Tamponade 3 3
Cardiac Arrest 3 3
Foreign Body In Patient 3 3
Cardiogenic Shock 3 3
Foreign Body Embolism 3 3
Tachycardia 3 3
Great Vessel Perforation 3 3
Cardiovascular Insufficiency 3 3
Pericardial Effusion 2 2
Thrombocytopenia 2 2
Hemorrhage/Bleeding 2 2
Tricuspid Valve Insufficiency/ Regurgitation 1 1
Rupture 1 1
Cusp Tear 1 1
Hemolytic Anemia 1 1
Pericarditis 1 1
Retroperitoneal Hemorrhage 1 1
Dyspnea 1 1
Low Blood Pressure/ Hypotension 1 1

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