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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 21

MDR Year MDR Reports MDR Events
2021 5604 22463
2022 5994 27667
2023 8319 29538
2024 11043 33815
2025 13120 39660
2026 5556 15597

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14493 61999
Patient Device Interaction Problem 8612 14114
Insufficient Information 6088 72472
Perivalvular Leak 5754 7438
Device Dislodged or Dislocated 3776 4338
Material Invagination 2198 2198
Central Regurgitation 2101 2102
Device Stenosis 2001 2020
Degraded 1933 1934
Gradient Increase 1795 1797
Calcified 1632 1633
Activation Failure 1626 1626
Fluid/Blood Leak 1522 3409
Malposition of Device 1404 1405
Burst Container or Vessel 1296 1298
Migration or Expulsion of Device 1267 4020
Difficult or Delayed Positioning 1205 1205
Difficult to Remove 1065 1066
Material Deformation 947 947
Difficult to Open or Close 713 714
Material Split, Cut or Torn 552 552
Difficult to Advance 545 545
Migration 519 585
Detachment of Device or Device Component 493 493
Thickening of Material 472 472
Inadequacy of Device Shape and/or Size 380 381
Material Separation 372 373
Difficult to Fold, Unfold or Collapse 361 361
Improper or Incorrect Procedure or Method 355 355
Particulates 333 333
Failure to Advance 323 323
Packaging Problem 271 271
Difficult to Open or Remove Packaging Material 257 257
Contamination /Decontamination Problem 248 248
Appropriate Term/Code Not Available 226 245
Material Twisted/Bent 221 221
No Apparent Adverse Event 210 210
Incomplete Coaptation 209 211
Inflation Problem 208 208
Positioning Problem 200 200
Retraction Problem 197 197
Device Difficult to Setup or Prepare 197 197
Material Rupture 193 193
Structural Problem 177 177
Patient-Device Incompatibility 161 163
Off-Label Use 146 146
Difficult or Delayed Activation 142 142
Peeled/Delaminated 124 124
Difficult to Insert 118 118
Physical Resistance/Sticking 116 116

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 10835 10839
Insufficient Information 7356 17556
Heart Block 7220 37239
Non specific EKG/ECG Changes 3735 16482
Valvular Insufficiency/ Regurgitation 3475 6718
Stroke/CVA 3231 12758
Aortic Valve Insufficiency/ Regurgitation 2724 6407
Heart Failure/Congestive Heart Failure 2558 3842
Dyspnea 2372 2373
Vascular Dissection 1795 5711
Hemorrhage/Bleeding 1791 9647
Low Blood Pressure/ Hypotension 1614 1614
Obstruction/Occlusion 1334 3296
Rupture 1264 1717
Foreign Body In Patient 1217 2791
Thrombosis/Thrombus 1181 4574
Cardiac Arrest 1082 8081
Aortic Valve Stenosis 877 908
Myocardial Infarction 844 6309
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 781 12140
Pericardial Effusion 697 697
Atrial Fibrillation 651 3412
Endocarditis 624 3555
Cardiac Tamponade 604 684
Arrhythmia 497 5203
Cardiac Perforation 496 2690
Renal Failure 439 3443
Bradycardia 425 425
Cardiovascular Insufficiency 389 11012
Fatigue 389 389
Chest Pain 354 354
Ischemia Stroke 312 6020
Unspecified Vascular Problem 308 1379
Mitral Valve Insufficiency/ Regurgitation 307 307
Tachycardia 294 295
Perforation 291 3247
Perforation of Vessels 285 350
Hematoma 284 3166
Unspecified Infection 263 1324
Ventricular Fibrillation 257 257
Transient Ischemic Attack 254 4003
Stenosis 240 240
Hemolytic Anemia 234 234
Anemia 232 232
Cardiogenic Shock 224 224
Hemolysis 211 211
Syncope/Fainting 201 201
Pseudoaneurysm 200 200
Calcium Deposits/Calcification 186 186
Swelling/ Edema 165 165

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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