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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 26

MDR Year MDR Reports MDR Events
2019 4361 9090
2020 5806 16016
2021 5605 22452
2022 5994 27660
2023 8321 29536
2024 7245 24679

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 15097 54744
Insufficient Information 4392 55884
Perivalvular Leak 3975 4205
Patient Device Interaction Problem 3246 5913
Device Dislodged or Dislocated 3197 3602
Malposition of Device 1377 1377
Gradient Increase 1216 1216
Fluid/Blood Leak 1168 1215
Degraded 1119 1119
Burst Container or Vessel 1091 1091
Difficult to Remove 1028 1028
Calcified 935 935
Material Invagination 817 817
Migration or Expulsion of Device 765 1818
Material Deformation 744 744
Material Split, Cut or Torn 731 731
Difficult or Delayed Positioning 693 693
Activation Failure 693 693
Central Regurgitation 656 656
Device Stenosis 577 583
Material Separation 548 548
Difficult to Advance 513 513
Migration 493 546
Material Rupture 454 454
Difficult to Open or Close 449 449
Appropriate Term/Code Not Available 356 398
Physical Resistance/Sticking 325 325
Failure to Advance 323 323
Material Twisted/Bent 286 286
Positioning Problem 276 502
Detachment of Device or Device Component 259 259
Inadequacy of Device Shape and/or Size 255 255
Incomplete Coaptation 220 220
Improper or Incorrect Procedure or Method 203 203
Inflation Problem 190 190
Difficult to Insert 178 178
Leak/Splash 143 143
Peeled/Delaminated 140 140
No Apparent Adverse Event 131 131
Thickening of Material 129 129
Structural Problem 119 119
Patient-Device Incompatibility 115 117
Break 114 114
Difficult to Fold, Unfold or Collapse 103 103
Activation, Positioning or Separation Problem 101 101
Difficult or Delayed Activation 95 95
Deformation Due to Compressive Stress 94 94
Unintended Movement 86 86
Retraction Problem 85 85
Fracture 85 85

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4957 4957
Heart Block 4401 24787
Insufficient Information 4315 13400
Non specific EKG/ECG Changes 3338 9840
Stroke/CVA 2745 8900
Valvular Insufficiency/ Regurgitation 1901 2119
Vascular Dissection 1653 3841
Complete Heart Block 1579 1580
Hemorrhage/Bleeding 1522 6271
Aortic Valve Insufficiency/ Regurgitation 1397 2855
Heart Failure/Congestive Heart Failure 1311 1863
Low Blood Pressure/ Hypotension 1308 1308
No Known Impact Or Consequence To Patient 1307 1320
Rupture 1240 1521
Dyspnea 1191 1193
Arrhythmia 1191 7676
Injury 1150 4478
Obstruction/Occlusion 1117 2753
Death 967 2416
No Consequences Or Impact To Patient 966 966
Myocardial Infarction 840 3553
Cardiac Arrest 807 4601
Aortic Regurgitation 785 813
Aortic Valve Stenosis 783 802
Thrombosis/Thrombus 637 2124
Atrial Fibrillation 625 1675
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 620 8892
Blood Loss 562 717
Pericardial Effusion 527 527
Cardiac Tamponade 517 632
Calcium Deposits/Calcification 515 515
Endocarditis 499 1823
Foreign Body In Patient 438 439
Bradycardia 423 423
Cardiac Perforation 419 2289
No Code Available 407 511
Insufficiency, Valvular 407 407
Vascular System (Circulation), Impaired 332 1413
Stenosis 328 328
Infarction, Cerebral 315 693
Cardiovascular Insufficiency 312 6885
Perforation of Vessels 296 361
Perforation 294 1542
Renal Failure 291 800
Transient Ischemic Attack 282 2038
Hematoma 266 1576
Occlusion 254 259
Unspecified Infection 231 868
Chest Pain 227 227
Ventricular Fibrillation 227 227

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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