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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 7

MDR Year MDR Reports MDR Events
2024 133 133
2025 333 333
2026 351 474

Device Problems MDRs with this Device Problem Events in those MDRs
Patient Device Interaction Problem 343 343
Insufficient Information 221 344
Malposition of Device 90 90
Migration 77 77
Difficult to Insert 34 34
Central Regurgitation 26 26
Perivalvular Leak 18 18
Device-Device Incompatibility 17 17
Adverse Event Without Identified Device or Use Problem 11 11
Difficult or Delayed Activation 6 6
Gradient Increase 5 5
Difficult to Remove 4 4
Activation, Positioning or Separation Problem 4 4
Device Stenosis 4 4
Detachment of Device or Device Component 3 3
Particulates 3 3
Material Integrity Problem 3 3
Defective Component 2 2
Separation Failure 1 1
Degraded 1 1
Mechanical Problem 1 1
Migration or Expulsion of Device 1 1
Premature Separation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Heart Block 367 480
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 57 180
Thrombosis/Thrombus 53 53
Bradycardia 46 46
Cardiac Perforation 44 44
Failure of Implant 37 37
No Clinical Signs, Symptoms or Conditions 37 37
Insufficient Information 35 35
Arrhythmia 32 42
Foreign Body Embolism 32 32
Heart Failure/Congestive Heart Failure 25 25
Perforation of Vessels 24 24
Tricuspid Valve Insufficiency/ Regurgitation 14 14
Unspecified Vascular Problem 10 123
Cardiovascular Insufficiency 9 9
Cardiac Arrest 8 8
Hemolysis 7 7
Asystole 7 7
Great Vessel Perforation 6 6
Foreign Body In Patient 5 5
Hematoma 4 127
Hemorrhage/Bleeding 4 127
Tachycardia 4 4
Pericardial Effusion 3 3
Cardiac Tamponade 3 3
Cardiogenic Shock 3 3
Low Blood Pressure/ Hypotension 2 2
Thrombocytopenia 2 2
Pseudoaneurysm 2 2
Dyspnea 2 2
Cusp Tear 2 2
Rupture 2 2
Retroperitoneal Hemorrhage 1 1
Renal Failure 1 1
Ventricular Fibrillation 1 1
Tricuspid Valve Stenosis 1 1
Myocardial Infarction 1 1
Pericarditis 1 1
Hemolytic Anemia 1 1
Transient Ischemic Attack 1 1
Anemia 1 1
Stroke/CVA 1 114
Syncope/Fainting 1 1
Pocket Erosion 1 11
Ischemia Stroke 1 1
Fistula 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Edwards Lifesciences, LLC II May-13-2026
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