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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 20

MDR Year MDR Reports MDR Events
2019 4361 9090
2020 5806 16016
2021 5605 22452
2022 5994 27660
2023 8321 29536
2024 5498 16649

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14680 51393
Insufficient Information 4154 52585
Perivalvular Leak 3754 3974
Device Dislodged or Dislocated 3066 3444
Patient Device Interaction Problem 2830 4052
Malposition of Device 1349 1349
Gradient Increase 1150 1150
Fluid/Blood Leak 1112 1145
Degraded 1054 1054
Burst Container or Vessel 1048 1048
Difficult to Remove 1001 1001
Calcified 850 850
Material Invagination 727 727
Material Split, Cut or Torn 721 721
Migration or Expulsion of Device 718 1165
Material Deformation 712 712
Difficult or Delayed Positioning 653 653
Activation Failure 627 627
Central Regurgitation 543 543
Material Separation 540 540
Difficult to Advance 481 481
Migration 478 529
Device Stenosis 472 476
Material Rupture 450 450
Difficult to Open or Close 431 431
Appropriate Term/Code Not Available 346 388
Physical Resistance/Sticking 323 323
Failure to Advance 315 315
Material Twisted/Bent 279 279
Positioning Problem 256 482
Detachment of Device or Device Component 250 250
Inadequacy of Device Shape and/or Size 245 245
Incomplete Coaptation 210 210
Improper or Incorrect Procedure or Method 194 194
Inflation Problem 181 181
Difficult to Insert 175 175
Leak/Splash 143 143
Peeled/Delaminated 140 140
No Apparent Adverse Event 126 126
Structural Problem 114 114
Break 113 113
Patient-Device Incompatibility 108 110
Thickening of Material 105 105
Activation, Positioning or Separation Problem 101 101
Difficult to Fold, Unfold or Collapse 96 96
Deformation Due to Compressive Stress 92 92
Difficult or Delayed Activation 87 87
Unintended Movement 86 86
Fracture 84 84
Failure to Align 76 76
Material Puncture/Hole 75 75
Use of Device Problem 74 74
Activation Problem 74 74
Retraction Problem 71 71
Obstruction of Flow 70 81
Backflow 69 69
Entrapment of Device 64 64
Particulates 63 63
Material Integrity Problem 61 61
Device Damaged by Another Device 60 60
Material Protrusion/Extrusion 59 59
Positioning Failure 59 65
Material Fragmentation 57 57
Off-Label Use 52 52
Deflation Problem 50 50
Inaccurate Delivery 44 44
Mechanical Problem 43 46
Separation Problem 42 42
Therapeutic or Diagnostic Output Failure 42 42
Device Slipped 39 39
Device Difficult to Setup or Prepare 35 35
Contamination /Decontamination Problem 27 27
Failure to Conduct 21 165
Mechanical Jam 20 20
Defective Device 18 18
Device-Device Incompatibility 17 17
Nonstandard Device 17 17
Pacing Problem 16 142
Loss of or Failure to Bond 16 16
Device Markings/Labelling Problem 16 16
Crack 14 14
Unintended Collision 14 14
Reflux within Device 13 13
Mechanics Altered 13 13
Coagulation in Device or Device Ingredient 11 31
Complete Blockage 10 10
Contamination 9 9
Device Contaminated During Manufacture or Shipping 9 9
Device Contamination with Chemical or Other Material 9 9
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 4579 4579
Heart Block 4189 22981
Insufficient Information 4025 12128
Non specific EKG/ECG Changes 3203 8866
Stroke/CVA 2663 7763
Valvular Insufficiency/ Regurgitation 1756 1964
Vascular Dissection 1589 3138
Complete Heart Block 1579 1580
Hemorrhage/Bleeding 1468 5310
No Known Impact Or Consequence To Patient 1307 1320
Aortic Valve Insufficiency/ Regurgitation 1298 2621
Low Blood Pressure/ Hypotension 1254 1254
Heart Failure/Congestive Heart Failure 1217 1636
Rupture 1197 1455
Arrhythmia 1177 7662
Injury 1150 4478
Dyspnea 1089 1091
Obstruction/Occlusion 1073 2096
Death 967 2416
No Consequences Or Impact To Patient 966 966
Myocardial Infarction 815 2703
Aortic Regurgitation 785 813
Cardiac Arrest 775 3788
Aortic Valve Stenosis 759 776
Atrial Fibrillation 603 1047
Thrombosis/Thrombus 593 1436
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 589 8339
Blood Loss 562 717
Pericardial Effusion 507 507
Calcium Deposits/Calcification 504 504
Cardiac Tamponade 499 611
Endocarditis 484 1184
Foreign Body In Patient 415 416
No Code Available 407 511
Bradycardia 407 407
Insufficiency, Valvular 407 407
Cardiac Perforation 405 2177
Vascular System (Circulation), Impaired 332 1413
Infarction, Cerebral 315 693
Stenosis 310 310
Cardiovascular Insufficiency 299 6335
Perforation of Vessels 289 354
Perforation 280 888
Transient Ischemic Attack 276 1366
Renal Failure 276 753
Hematoma 259 963
Occlusion 254 259
Unspecified Infection 222 735
Ventricular Fibrillation 218 218
Chest Pain 216 216
Aortic Dissection 211 258
Unspecified Vascular Problem 210 1352
No Information 191 4699
Ischemia Stroke 191 3586
Tachycardia 190 190
Pseudoaneurysm 180 180
Cardiogenic Shock 172 172
Aortic Insufficiency 159 164
Thrombosis 154 186
Anemia 152 152
Mitral Valve Insufficiency/ Regurgitation 149 149
Failure of Implant 148 148
Fatigue 144 145
Paralysis 133 133
Ischemia 124 507
Hemolysis 115 115
Intimal Dissection 114 114
Fever 112 112
High Blood Pressure/ Hypertension 111 111
Muscle Weakness 111 111
Low Cardiac Output 110 110
Thromboembolism 100 100
Syncope/Fainting 100 100
Thrombus 99 101
Regurgitation 97 97
Sepsis 94 94
Dizziness 93 93
Foreign Body Embolism 91 91
Unspecified Tissue Injury 91 91
Mitral Regurgitation 90 90
Pain 90 91
Pleural Effusion 89 89
Pneumonia 87 87
No Patient Involvement 86 86
Hemolytic Anemia 85 85
Pulmonary Edema 85 85
Swelling/ Edema 85 85
Heart Failure 84 84
Regurgitation, Valvular 80 80
Congestive Heart Failure 80 80
Cusp Tear 75 75
Embolism/Embolus 72 72
Cardiac Enzyme Elevation 71 71
Great Vessel Perforation 70 70
Dysphasia 63 63
Angina 62 62
Loss of consciousness 60 60
Fistula 59 59
Valvular Stenosis 59 59
Speech Disorder 58 58

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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