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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, non-allograft tissue
Product CodeLWR
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
18 37 26 27 27 5

MDR Year MDR Reports MDR Events
2021 1550 1551
2022 1084 1086
2023 1592 1600
2024 1829 1850
2025 1884 1884
2026 250 263

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2951 2962
Central Regurgitation 945 964
Adverse Event Without Identified Device or Use Problem 926 934
Device Stenosis 852 870
Patient Device Interaction Problem 732 736
Degraded 651 667
Calcified 586 599
Perivalvular Leak 524 524
Gradient Increase 517 519
Material Split, Cut or Torn 466 467
Patient-Device Incompatibility 352 353
Incomplete Coaptation 325 326
Fluid/Blood Leak 292 292
Backflow 213 213
Inadequacy of Device Shape and/or Size 187 188
Obstruction of Flow 142 142
Difficult to Open or Close 115 116
Detachment of Device or Device Component 80 80
Biocompatibility 60 60
Leak/Splash 54 55
Thickening of Material 50 63
Material Deformation 43 43
Device Dislodged or Dislocated 42 42
Off-Label Use 40 40
Break 38 39
Appropriate Term/Code Not Available 31 33
Collapse 30 30
Malposition of Device 30 30
Material Separation 28 29
Positioning Failure 24 24
Mechanical Jam 23 23
Microbial Contamination of Device 22 22
Migration 20 20
Partial Blockage 19 19
Use of Device Problem 16 16
Therapeutic or Diagnostic Output Failure 15 15
Material Puncture/Hole 14 14
Material Too Rigid or Stiff 13 13
Unsealed Device Packaging 11 11
Reflux within Device 11 12
Entrapment of Device 11 11
Difficult or Delayed Separation 10 10
Migration or Expulsion of Device 10 10
Fracture 9 9
Improper or Incorrect Procedure or Method 9 9
Difficult to Fold, Unfold or Collapse 7 7
Nonstandard Device 7 7
Defective Device 7 7
Packaging Problem 7 7
Deformation Due to Compressive Stress 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 3368 3395
Aortic Valve Insufficiency/ Regurgitation 1717 1725
Aortic Valve Stenosis 907 913
Heart Failure/Congestive Heart Failure 872 886
Dyspnea 813 827
No Clinical Signs, Symptoms or Conditions 586 590
Endocarditis 577 577
Mitral Valve Insufficiency/ Regurgitation 265 267
Thrombosis/Thrombus 250 250
Heart Block 235 237
Stroke/CVA 235 235
Hemorrhage/Bleeding 225 225
Fatigue 177 190
Atrial Fibrillation 169 169
Calcium Deposits/Calcification 158 158
Non specific EKG/ECG Changes 130 131
Mitral Valve Stenosis 101 101
Renal Failure 101 101
Valvular Insufficiency/ Regurgitation 96 97
Chest Pain 88 88
Myocardial Infarction 79 79
Unspecified Infection 73 73
Arrhythmia 71 71
Obstruction/Occlusion 71 72
Cusp Tear 69 70
Tachycardia 62 62
Pulmonary Valve Stenosis 54 54
Pseudoaneurysm 54 54
Pulmonary Valve Insufficiency/ Regurgitation 53 53
Cardiac Arrest 50 50
Bradycardia 47 47
Angina 47 47
Tricuspid Valve Insufficiency/ Regurgitation 47 47
Pulmonary Edema 46 46
Cardiogenic Shock 46 46
Fever 45 45
Thrombocytopenia 45 45
Pericardial Effusion 44 44
Aneurysm 44 44
Low Blood Pressure/ Hypotension 42 42
Rupture 42 42
Cardiac Tamponade 39 39
Pleural Effusion 37 38
Syncope/Fainting 34 47
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 32 34
Swelling/ Edema 32 32
Sepsis 32 32
Foreign Body Reaction 31 31
Failure of Implant 29 29
Abscess 29 29

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