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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)
2021 2022 2023 2024 2025 2026
0 0 0 10 10 0

MDR Year MDR Reports MDR Events
2024 133 133
2025 333 333

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 274 274
Malposition of Device 71 71
Migration 57 57
Difficult to Insert 28 28
Central Regurgitation 26 26
Perivalvular Leak 16 16
Device-Device Incompatibility 13 13
Activation, Positioning or Separation Problem 4 4
Difficult to Remove 4 4
Gradient Increase 4 4
Device Stenosis 3 3
Material Integrity Problem 3 3
Particulates 3 3
Detachment of Device or Device Component 3 3
Insufficient Information 2 2
Defective Component 2 2
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Separation Failure 1 1
Degraded 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Heart Block 182 182
Thrombosis/Thrombus 43 43
Failure of Implant 37 37
Bradycardia 37 37
Insufficient Information 29 29
No Clinical Signs, Symptoms or Conditions 28 28
Cardiac Perforation 27 27
Arrhythmia 24 24
Perforation of Vessels 19 19
Foreign Body Embolism 17 17
Heart Failure/Congestive Heart Failure 17 17
Cardiovascular Insufficiency 7 7
Hemolysis 5 5
Cardiac Arrest 5 5
Asystole 5 5
Great Vessel Perforation 5 5
Foreign Body In Patient 4 4
Tachycardia 4 4
Pericardial Effusion 3 3
Cardiac Tamponade 3 3
Cardiogenic Shock 3 3
Tricuspid Valve Insufficiency/ Regurgitation 2 2
Cusp Tear 2 2
Dyspnea 2 2
Thrombocytopenia 2 2
Hemorrhage/Bleeding 2 2
Low Blood Pressure/ Hypotension 2 2
Hematoma 1 1
Anemia 1 1
Rupture 1 1
Hemolytic Anemia 1 1
Pericarditis 1 1
Ventricular Fibrillation 1 1
Retroperitoneal Hemorrhage 1 1
Renal Failure 1 1
Pseudoaneurysm 1 1
Fistula 1 1

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