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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, mechanical
Product CodeLWQ
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
9 8 9 6 9 1

MDR Year MDR Reports MDR Events
2021 287 287
2022 297 297
2023 455 455
2024 404 405
2025 336 336
2026 56 56

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 538 538
Insufficient Information 338 338
Physical Resistance/Sticking 198 198
Incomplete Coaptation 185 185
Patient Device Interaction Problem 163 164
Perivalvular Leak 108 108
Fracture 89 89
Detachment of Device or Device Component 83 83
Inadequacy of Device Shape and/or Size 53 54
Patient-Device Incompatibility 53 53
Device Stenosis 46 46
Central Regurgitation 41 41
Difficult to Open or Close 35 35
Material Separation 34 34
Biocompatibility 27 27
Gradient Increase 22 22
Appropriate Term/Code Not Available 14 14
Obstruction of Flow 14 14
Improper or Incorrect Procedure or Method 13 13
Off-Label Use 12 12
Material Split, Cut or Torn 12 12
Break 11 11
Backflow 10 10
Device Markings/Labelling Problem 10 10
No Apparent Adverse Event 7 7
Degraded 6 6
Contamination /Decontamination Problem 5 5
Use of Device Problem 5 5
Mechanical Jam 5 5
Packaging Problem 4 4
Product Quality Problem 3 3
Unsealed Device Packaging 3 3
Migration or Expulsion of Device 3 3
Mechanical Problem 3 3
Leak/Splash 3 3
Device Damaged by Another Device 2 2
Material Integrity Problem 2 2
Crack 2 2
Device Dislodged or Dislocated 2 2
Thickening of Material 2 2
Material Frayed 2 2
Positioning Problem 1 1
Material Fragmentation 1 1
Shipping Damage or Problem 1 1
Defective Device 1 1
Expiration Date Error 1 1
Insufficient Flow or Under Infusion 1 1
Mechanics Altered 1 1
Lack of Effect 1 1
Device Handling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 512 512
No Clinical Signs, Symptoms or Conditions 415 415
Thrombosis/Thrombus 143 143
Stroke/CVA 134 134
Hemorrhage/Bleeding 133 133
Endocarditis 99 99
Heart Failure/Congestive Heart Failure 97 97
Aortic Valve Insufficiency/ Regurgitation 94 94
Atrial Fibrillation 79 79
Dyspnea 75 75
Heart Block 70 70
Aortic Valve Stenosis 56 56
Mitral Valve Insufficiency/ Regurgitation 55 55
Valvular Insufficiency/ Regurgitation 50 50
Non specific EKG/ECG Changes 49 49
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 43 43
Renal Failure 36 36
Arrhythmia 35 35
Thromboembolism 34 34
Unspecified Infection 33 33
Obstruction/Occlusion 33 34
Pseudoaneurysm 32 32
Anemia 31 31
Pericardial Effusion 31 31
Myocardial Infarction 30 30
Tachycardia 28 28
Cardiac Arrest 24 24
Pleural Effusion 24 24
Mitral Valve Stenosis 24 24
Hematoma 20 20
Transient Ischemic Attack 18 18
Cardiac Tamponade 18 18
Embolism/Embolus 18 18
Low Blood Pressure/ Hypotension 17 17
Unspecified Heart Problem 17 17
Angina 16 16
Ventricular Fibrillation 16 16
Pneumonia 15 15
Fatigue 14 14
Chest Pain 14 14
Hemolysis 14 14
Respiratory Insufficiency 14 14
Pulmonary Edema 13 13
Bradycardia 13 13
Hypoxia 12 12
Syncope/Fainting 12 12
Cardiogenic Shock 12 12
Intracranial Hemorrhage 11 11
Foreign Body Reaction 11 11
Sepsis 10 10

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