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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aortic valve, prosthesis, percutaneously delivered
Definition To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPT
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
59 48 42 41 49 11

MDR Year MDR Reports MDR Events
2019 4361 9090
2020 5806 16016
2021 5605 22452
2022 5994 27660
2023 8321 29536
2024 2900 8682

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14001 48667
Insufficient Information 3843 49029
Perivalvular Leak 3420 3628
Device Dislodged or Dislocated 2887 3236
Patient Device Interaction Problem 2158 3380
Malposition of Device 1264 1264
Gradient Increase 1051 1051
Fluid/Blood Leak 1030 1043
Burst Container or Vessel 993 993
Difficult to Remove 947 947
Degraded 940 940
Calcified 767 767
Material Split, Cut or Torn 705 705
Material Deformation 658 658
Migration or Expulsion of Device 627 1074
Difficult or Delayed Positioning 597 597
Material Invagination 592 592
Material Separation 527 527
Activation Failure 506 506
Difficult to Advance 450 450
Material Rupture 446 446
Migration 445 492
Difficult to Open or Close 388 388
Central Regurgitation 361 361
Appropriate Term/Code Not Available 335 369
Physical Resistance/Sticking 317 317
Failure to Advance 299 299
Device Stenosis 298 298
Material Twisted/Bent 267 267
Positioning Problem 243 469
Detachment of Device or Device Component 240 240
Inadequacy of Device Shape and/or Size 227 227
Incomplete Coaptation 196 196
Inflation Problem 173 173
Difficult to Insert 168 168
Improper or Incorrect Procedure or Method 164 164
Leak/Splash 142 142
Peeled/Delaminated 138 138
No Apparent Adverse Event 120 120
Break 113 113
Structural Problem 110 110
Activation, Positioning or Separation Problem 101 101
Patient-Device Incompatibility 99 101
Deformation Due to Compressive Stress 91 91
Difficult or Delayed Activation 85 85
Unintended Movement 84 84
Fracture 82 82
Material Puncture/Hole 75 75
Failure to Align 75 75
Difficult to Fold, Unfold or Collapse 74 74
Activation Problem 71 71
Backflow 69 69
Obstruction of Flow 69 80
Use of Device Problem 68 68
Thickening of Material 67 67
Entrapment of Device 64 64
Particulates 63 63
Retraction Problem 59 59
Positioning Failure 58 64
Device Damaged by Another Device 57 57
Material Integrity Problem 57 57
Material Protrusion/Extrusion 54 54
Material Fragmentation 50 50
Deflation Problem 50 50
Inaccurate Delivery 44 44
Mechanical Problem 43 46
Therapeutic or Diagnostic Output Failure 42 42
Separation Problem 37 37
Off-Label Use 34 34
Device Slipped 34 34
Device Difficult to Setup or Prepare 31 31
Contamination /Decontamination Problem 26 26
Failure to Conduct 21 165
Mechanical Jam 20 20
Defective Device 18 18
Device-Device Incompatibility 17 17
Device Markings/Labelling Problem 16 16
Loss of or Failure to Bond 16 16
Pacing Problem 16 142
Unintended Collision 14 14
Reflux within Device 13 13
Nonstandard Device 12 12
Crack 12 12
Coagulation in Device or Device Ingredient 11 31
Complete Blockage 10 10
Contamination 9 9
Device Contamination with Chemical or Other Material 9 9
Mechanics Altered 9 9
Device Contaminated During Manufacture or Shipping 8 8
Separation Failure 8 8
Material Perforation 8 8
Partial Blockage 8 8
Incorrect, Inadequate or Imprecise Result or Readings 8 8
Component Missing 7 7
Stretched 7 7
Tear, Rip or Hole in Device Packaging 7 7
Misassembly by Users 7 7
Device Handling Problem 6 6
Inaccurate Information 6 6
Microbial Contamination of Device 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4073 4073
Heart Block 3761 21111
Insufficient Information 3612 11403
Non specific EKG/ECG Changes 3022 7893
Stroke/CVA 2483 7306
Complete Heart Block 1579 1580
Valvular Insufficiency/ Regurgitation 1577 1773
Vascular Dissection 1475 2996
Hemorrhage/Bleeding 1380 5000
No Known Impact Or Consequence To Patient 1307 1320
Low Blood Pressure/ Hypotension 1166 1166
Aortic Valve Insufficiency/ Regurgitation 1155 2376
Arrhythmia 1154 7592
Injury 1150 4478
Rupture 1144 1371
Heart Failure/Congestive Heart Failure 1039 1424
Obstruction/Occlusion 990 1999
Death 967 2416
No Consequences Or Impact To Patient 966 966
Dyspnea 961 963
Aortic Regurgitation 785 813
Myocardial Infarction 765 2525
Aortic Valve Stenosis 720 733
Cardiac Arrest 716 3554
Atrial Fibrillation 571 1015
Blood Loss 562 717
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 559 7745
Thrombosis/Thrombus 517 1330
Calcium Deposits/Calcification 495 495
Cardiac Tamponade 472 580
Pericardial Effusion 464 464
Endocarditis 444 1107
Insufficiency, Valvular 407 407
No Code Available 407 511
Cardiac Perforation 381 2067
Bradycardia 373 373
Foreign Body In Patient 365 366
Vascular System (Circulation), Impaired 332 1413
Infarction, Cerebral 315 693
Stenosis 299 299
Cardiovascular Insufficiency 284 5746
Perforation of Vessels 279 344
Transient Ischemic Attack 265 1300
Perforation 263 844
Renal Failure 257 706
Occlusion 254 259
Hematoma 239 943
Aortic Dissection 211 258
Ventricular Fibrillation 208 208
Unspecified Infection 207 698
Unspecified Vascular Problem 195 1337
Chest Pain 194 194
No Information 191 4699
Ischemia Stroke 177 3299
Tachycardia 175 175
Pseudoaneurysm 167 167
Aortic Insufficiency 159 164
Cardiogenic Shock 157 157
Thrombosis 154 186
Failure of Implant 144 144
Anemia 137 137
Mitral Valve Insufficiency/ Regurgitation 130 130
Fatigue 126 127
Paralysis 124 124
Ischemia 118 501
Intimal Dissection 114 114
Low Cardiac Output 108 108
High Blood Pressure/ Hypertension 102 102
Fever 101 101
Hemolysis 100 100
Muscle Weakness 100 100
Thrombus 99 101
Regurgitation 97 97
Thromboembolism 91 91
Mitral Regurgitation 90 90
Syncope/Fainting 90 90
Dizziness 87 87
No Patient Involvement 86 86
Foreign Body Embolism 86 86
Unspecified Tissue Injury 85 85
Heart Failure 84 84
Sepsis 83 83
Pleural Effusion 83 83
Pain 82 83
Congestive Heart Failure 80 80
Regurgitation, Valvular 80 80
Pulmonary Edema 77 77
Cusp Tear 72 72
Swelling/ Edema 72 72
Embolism/Embolus 68 68
Hemolytic Anemia 67 67
Cardiac Enzyme Elevation 66 66
Great Vessel Perforation 63 63
Dysphasia 60 60
Pneumonia 60 60
Embolism 58 58
Speech Disorder 57 57
Paresis 56 56
Pulmonary Dysfunction 55 643
Loss of consciousness 55 55

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-09-2021
2 Edwards Lifesciences, LLC I Aug-21-2019
3 Edwards Lifesciences, LLC II Feb-14-2019
4 Medtronic Heart Valves Division II Jul-09-2021
5 Medtronic Heart Valves Division II Dec-10-2020
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