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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement heart-valve
Regulation Description Replacement heart valve.
Definition Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product CodeDYE
Regulation Number 870.3925
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
13 7 8 11 7 6

MDR Year MDR Reports MDR Events
2020 2466 2466
2021 2833 2833
2022 2566 2566
2023 3494 3494
2024 3452 3452
2025 1473 1473

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6821 6821
Gradient Increase 5443 5443
Degraded 2383 2383
Fluid/Blood Leak 2379 2379
Calcified 2002 2002
Device Stenosis 1873 1873
Adverse Event Without Identified Device or Use Problem 964 964
Patient Device Interaction Problem 960 960
Central Regurgitation 763 763
Difficult to Open or Close 568 568
Appropriate Term/Code Not Available 482 482
Perivalvular Leak 427 427
Incomplete Coaptation 306 306
Material Split, Cut or Torn 188 188
Inadequacy of Device Shape and/or Size 132 132
Thickening of Material 104 104
Patient-Device Incompatibility 84 84
Structural Problem 83 83
Detachment of Device or Device Component 76 76
Break 59 59
Therapeutic or Diagnostic Output Failure 51 51
Mechanical Jam 50 50
Entrapment of Device 36 36
Obstruction of Flow 26 26
Microbial Contamination of Device 20 20
Off-Label Use 15 15
Device Dislodged or Dislocated 15 15
Leak/Splash 14 14
Material Separation 14 14
Material Integrity Problem 13 13
Unintended Movement 11 11
Fracture 10 10
Partial Blockage 10 10
Contamination /Decontamination Problem 10 10
Backflow 9 9
Malposition of Device 9 9
Material Puncture/Hole 9 9
Material Perforation 8 8
Material Deformation 8 8
Mechanical Problem 7 7
Pitted 7 7
Material Too Rigid or Stiff 6 6
Naturally Worn 6 6
Material Twisted/Bent 6 6
Separation Problem 5 5
Unsealed Device Packaging 5 5
Reflux within Device 5 5
Particulates 5 5
Packaging Problem 5 5
Contamination 4 4

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 8301 8301
Heart Failure/Congestive Heart Failure 2845 2845
Dyspnea 2613 2613
Aortic Valve Stenosis 2327 2327
Aortic Valve Insufficiency/ Regurgitation 1232 1232
Mitral Valve Stenosis 572 572
Aortic Regurgitation 461 461
Fatigue 442 442
Endocarditis 437 437
Stenosis 346 346
Chest Pain 315 315
Mitral Regurgitation 310 310
No Clinical Signs, Symptoms or Conditions 305 305
No Known Impact Or Consequence To Patient 255 255
Regurgitation 242 242
No Information 238 238
Calcium Deposits/Calcification 213 213
Non specific EKG/ECG Changes 178 178
Mitral Valve Insufficiency/ Regurgitation 169 169
Dizziness 156 156
Syncope/Fainting 141 141
Pulmonary Valve Stenosis 136 136
Congestive Heart Failure 135 135
Heart Block 112 112
Thrombosis/Thrombus 111 111
Atrial Fibrillation 109 109
Aortic Insufficiency 106 106
Cardiogenic Shock 105 105
Swelling/ Edema 99 99
Cusp Tear 88 88
Hemorrhage/Bleeding 85 85
Valvular Insufficiency/ Regurgitation 85 85
No Code Available 83 83
Pulmonary Regurgitation 75 75
Stroke/CVA 74 74
Failure of Implant 73 73
Tricuspid Valve Stenosis 63 63
Death 55 55
Pulmonary Valve Insufficiency/ Regurgitation 42 42
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 42 42
Tachycardia 41 41
Corneal Pannus 41 41
Cardiac Arrest 40 41
Obstruction/Occlusion 37 37
Tricuspid Regurgitation 35 35
Unspecified Infection 34 34
Low Blood Pressure/ Hypotension 33 33
Bradycardia 33 33
Cardiomyopathy 32 32
Thrombosis 31 31

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