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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)
2021 2022 2023 2024 2025 2026
42 41 49 33 29 5

MDR Year MDR Reports MDR Events
2021 5604 22463
2022 5994 27667
2023 8319 29538
2024 11043 33815
2025 13121 39661
2026 1006 4776

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13544 58690
Patient Device Interaction Problem 7477 12673
Insufficient Information 5509 68832
Perivalvular Leak 5134 6581
Device Dislodged or Dislocated 3513 4069
Material Invagination 1953 1953
Central Regurgitation 1742 1743
Degraded 1737 1738
Device Stenosis 1675 1694
Gradient Increase 1568 1570
Activation Failure 1445 1445
Fluid/Blood Leak 1406 2993
Calcified 1403 1404
Malposition of Device 1295 1296
Burst Container or Vessel 1162 1164
Migration or Expulsion of Device 1124 3877
Difficult or Delayed Positioning 1083 1083
Difficult to Remove 983 984
Material Deformation 860 860
Difficult to Open or Close 671 672
Material Split, Cut or Torn 518 518
Difficult to Advance 494 494
Migration 482 547
Detachment of Device or Device Component 480 480
Thickening of Material 399 399
Material Separation 346 347
Inadequacy of Device Shape and/or Size 341 342
Improper or Incorrect Procedure or Method 308 308
Failure to Advance 297 297
Difficult to Fold, Unfold or Collapse 289 289
Particulates 243 243
Material Twisted/Bent 208 208
Appropriate Term/Code Not Available 199 218
Incomplete Coaptation 199 201
Material Rupture 186 186
Positioning Problem 186 186
Device Difficult to Setup or Prepare 185 185
Difficult to Open or Remove Packaging Material 182 182
Contamination /Decontamination Problem 181 181
Inflation Problem 180 180
No Apparent Adverse Event 179 179
Packaging Problem 175 175
Retraction Problem 165 165
Structural Problem 164 164
Patient-Device Incompatibility 147 149
Difficult or Delayed Activation 138 138
Off-Label Use 132 132
Peeled/Delaminated 123 123
Physical Resistance/Sticking 112 112
Difficult to Insert 112 112

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 9795 9799
Insufficient Information 6667 16573
Heart Block 6553 34844
Non specific EKG/ECG Changes 3512 15338
Valvular Insufficiency/ Regurgitation 3246 6252
Stroke/CVA 2923 12139
Heart Failure/Congestive Heart Failure 2281 3520
Aortic Valve Insufficiency/ Regurgitation 2274 5597
Dyspnea 2044 2045
Vascular Dissection 1723 5639
Hemorrhage/Bleeding 1652 9195
Low Blood Pressure/ Hypotension 1429 1429
Obstruction/Occlusion 1300 3262
Rupture 1183 1615
Thrombosis/Thrombus 1072 4440
Foreign Body In Patient 1037 2611
Cardiac Arrest 989 7788
Myocardial Infarction 793 6130
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 749 11623
Aortic Valve Stenosis 727 758
Atrial Fibrillation 601 3362
Pericardial Effusion 597 597
Endocarditis 580 3492
Cardiac Tamponade 544 621
Cardiac Perforation 452 2565
Arrhythmia 422 5128
Renal Failure 399 3371
Bradycardia 395 395
Cardiovascular Insufficiency 370 10445
Fatigue 318 318
Chest Pain 314 314
Ischemia Stroke 288 5634
Unspecified Vascular Problem 273 1344
Tachycardia 269 270
Perforation 267 3196
Perforation of Vessels 263 328
Mitral Valve Insufficiency/ Regurgitation 260 260
Hematoma 258 3140
Unspecified Infection 244 1277
Transient Ischemic Attack 240 3959
Ventricular Fibrillation 233 233
Stenosis 217 217
Hemolytic Anemia 211 211
Cardiogenic Shock 209 209
Anemia 208 208
Pseudoaneurysm 189 189
Hemolysis 189 189
Syncope/Fainting 182 182
Swelling/ Edema 152 152
Foreign Body Embolism 152 152

Recalls
Manufacturer Recall Class Date Posted
1 Abbott Medical II Nov-20-2024
2 Boston Scientific Corporation I Jan-09-2021
3 Medtronic Heart Valves Division II Jul-09-2021
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