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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)
2018 2019 2020 2021 2022 2023
43 59 48 42 41 35

MDR Year MDR Reports MDR Events
2018 3916 5380
2019 4361 9090
2020 5806 16016
2021 5605 22452
2022 5994 27660
2023 5375 18781

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14334 42102
Insufficient Information 3370 43784
Perivalvular Leak 3261 3450
Device Dislodged or Dislocated 2931 3222
Malposition of Device 1270 1270
Gradient Increase 1005 1005
Burst Container or Vessel 1002 1002
Fluid/Blood Leak 972 972
Difficult to Remove 963 963
Degraded 749 749
Material Split, Cut or Torn 726 726
Calcified 713 713
Material Deformation 612 612
Material Separation 592 592
Migration or Expulsion of Device 559 571
Difficult or Delayed Positioning 526 526
Patient Device Interaction Problem 509 509
Material Rupture 505 505
Activation Failure 466 466
Appropriate Term/Code Not Available 458 481
Difficult to Advance 450 450
Migration 418 461
Physical Resistance/Sticking 348 348
Difficult to Open or Close 313 313
Material Invagination 313 313
Positioning Problem 299 525
Failure to Advance 297 297
Leak/Splash 272 272
Detachment of Device or Device Component 265 265
Material Twisted/Bent 263 263
Incomplete Coaptation 225 225
Inadequacy of Device Shape and/or Size 204 204
Inflation Problem 188 188
Difficult to Insert 177 177
Peeled/Delaminated 151 151
Activation, Positioning or Separation Problem 141 141
Break 137 137
Improper or Incorrect Procedure or Method 134 134
Patient-Device Incompatibility 118 120
Structural Problem 114 114
Deformation Due to Compressive Stress 106 106
No Apparent Adverse Event 106 106
Unintended Movement 105 105
Failure to Align 90 90
Fracture 89 89
Material Puncture/Hole 87 87
Obstruction of Flow 86 97
Positioning Failure 82 88
Entrapment of Device 75 75
Material Integrity Problem 74 74
Activation Problem 72 72
Difficult or Delayed Activation 70 70
Particulates 68 68
Use of Device Problem 63 63
Torn Material 63 63
Central Regurgitation 62 62
Backflow 58 58
Mechanical Problem 57 60
Deflation Problem 56 56
Inaccurate Delivery 55 55
Device Stenosis 55 55
Material Fragmentation 54 54
Retraction Problem 52 52
Device Damaged by Another Device 48 48
Material Protrusion/Extrusion 48 48
Therapeutic or Diagnostic Output Failure 43 43
Difficult to Fold, Unfold or Collapse 35 35
Separation Problem 31 31
Failure to Conduct 28 172
Difficult To Position 28 28
Device Slipped 28 28
Defective Device 27 27
Contamination /Decontamination Problem 25 25
Thickening of Material 24 24
Mechanical Jam 21 21
Device Difficult to Setup or Prepare 21 21
Device-Device Incompatibility 19 19
Pacing Problem 17 143
Loss of or Failure to Bond 16 16
Reflux within Device 15 15
Crack 14 14
Off-Label Use 14 14
Complete Blockage 12 12
Coagulation in Device or Device Ingredient 12 32
Unintended Collision 12 12
Failure to Capture 11 11
Device Markings/Labelling Problem 11 11
Device Operates Differently Than Expected 9 9
Device Contamination with Chemical or Other Material 9 9
Stretched 9 9
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Contamination 8 8
Partial Blockage 8 8
Material Perforation 8 8
Separation Failure 8 8
Output Problem 8 8
Noise, Audible 8 8
Misassembly by Users 7 7
Human-Device Interface Problem 7 7
Component Missing 7 7

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3009 3009
Non specific EKG/ECG Changes 2960 6349
Heart Block 2843 15564
Insufficient Information 2691 9392
Stroke/CVA 2311 6046
Complete Heart Block 2272 2274
No Known Impact Or Consequence To Patient 1930 1944
Injury 1473 4801
Vascular Dissection 1362 2390
Arrhythmia 1347 7785
Hemorrhage/Bleeding 1305 4054
Death 1288 2741
Rupture 1192 1341
Valvular Insufficiency/ Regurgitation 1191 1368
Low Blood Pressure/ Hypotension 1176 1178
Aortic Regurgitation 1169 1198
No Consequences Or Impact To Patient 1134 1134
Aortic Valve Insufficiency/ Regurgitation 847 1826
Obstruction/Occlusion 836 1376
Aortic Valve Stenosis 759 770
Myocardial Infarction 743 1810
Blood Loss 718 873
Dyspnea 689 692
Heart Failure/Congestive Heart Failure 680 949
Cardiac Arrest 651 2711
Calcium Deposits/Calcification 650 652
No Code Available 622 726
Atrial Fibrillation 518 527
Cardiac Tamponade 488 593
Pericardial Effusion 452 452
Vascular System (Circulation), Impaired 443 1525
Infarction, Cerebral 428 808
Insufficiency, Valvular 425 425
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 425 6017
Endocarditis 395 589
Occlusion 385 391
Thrombosis/Thrombus 383 663
Cardiac Perforation 381 1356
Bradycardia 375 375
Stenosis 352 353
Perforation 288 813
Aortic Dissection 287 334
Foreign Body In Patient 281 282
No Information 279 6251
Perforation of Vessels 264 329
Transient Ischemic Attack 258 757
Hematoma 236 505
Aortic Insufficiency 222 227
Cardiovascular Insufficiency 210 4620
Renal Failure 209 602
Failure of Implant 207 207
Ventricular Fibrillation 203 203
Thrombosis 203 235
Regurgitation 172 172
Unspecified Infection 169 540
Unspecified Vascular Problem 166 1308
Chest Pain 158 158
Pseudoaneurysm 155 155
Ischemia Stroke 146 2373
Cardiogenic Shock 144 144
Thrombus 144 146
Tachycardia 135 135
Intimal Dissection 132 132
Mitral Regurgitation 130 130
Low Cardiac Output 113 113
Regurgitation, Valvular 112 112
Congestive Heart Failure 112 112
Heart Failure 111 112
Ischemia 110 493
Paralysis 98 98
Fatigue 95 96
Mitral Valve Insufficiency/ Regurgitation 95 95
Thromboembolism 88 88
No Patient Involvement 86 86
High Blood Pressure/ Hypertension 82 82
Anemia 79 80
Embolism 77 77
Fever 77 77
Foreign Body Embolism 75 75
Dizziness 72 72
Hemolysis 69 69
Muscle Weakness 69 69
Pulmonary Edema 66 66
Pain 64 65
Patient Problem/Medical Problem 63 64
Syncope/Fainting 62 62
Unspecified Tissue Injury 60 60
Pleural Effusion 60 60
Sepsis 60 60
Great Vessel Perforation 56 56
Cusp Tear 56 56
Fistula 55 55
Embolism/Embolus 54 54
Tissue Damage 52 53
Ventricular Tachycardia 50 50
Pulmonary Dysfunction 49 568
Valvular Stenosis 49 49
Loss of consciousness 48 48
Dysphasia 47 47
Cardiac Enzyme Elevation 46 46

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 Edwards Lifesciences, LLC II Jul-13-2018
5 Edwards Lifesciences, LLC I Jan-10-2018
6 Medtronic Heart Valves Division II Jul-09-2021
7 Medtronic Heart Valves Division II Dec-10-2020
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