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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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)
2020 2021 2022 2023 2024 2025
48 42 41 49 33 1

MDR Year MDR Reports MDR Events
2020 5806 16016
2021 5605 22452
2022 5994 27660
2023 8321 29536
2024 11047 33817
2025 1037 5917

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13900 57209
Insufficient Information 4634 57865
Patient Device Interaction Problem 4357 9186
Perivalvular Leak 4047 4515
Device Dislodged or Dislocated 3044 3497
Degraded 1292 1292
Gradient Increase 1246 1246
Malposition of Device 1214 1214
Material Invagination 1179 1179
Fluid/Blood Leak 1153 1516
Burst Container or Vessel 1027 1027
Calcified 1012 1012
Activation Failure 951 951
Difficult to Remove 929 929
Central Regurgitation 915 915
Device Stenosis 896 909
Migration or Expulsion of Device 832 3229
Material Deformation 761 761
Difficult or Delayed Positioning 737 737
Material Split, Cut or Torn 621 621
Difficult to Open or Close 510 510
Difficult to Advance 467 467
Migration 445 501
Material Separation 418 418
Material Rupture 292 292
Failure to Advance 280 280
Material Twisted/Bent 265 265
Inadequacy of Device Shape and/or Size 247 247
Detachment of Device or Device Component 240 240
Appropriate Term/Code Not Available 232 274
Improper or Incorrect Procedure or Method 221 221
Positioning Problem 216 442
Physical Resistance/Sticking 202 202
Thickening of Material 200 200
Incomplete Coaptation 197 197
Inflation Problem 154 154
No Apparent Adverse Event 147 147
Difficult to Fold, Unfold or Collapse 146 146
Difficult to Insert 142 142
Structural Problem 134 134
Difficult or Delayed Activation 115 115
Peeled/Delaminated 111 111
Patient-Device Incompatibility 103 105
Retraction Problem 88 88
Use of Device Problem 77 77
Fracture 76 76
Leak/Splash 70 70
Off-Label Use 69 69
Backflow 68 68
Deformation Due to Compressive Stress 68 68

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 6254 6254
Heart Block 4996 26908
Insufficient Information 4976 16213
Non specific EKG/ECG Changes 3074 11259
Stroke/CVA 2599 10873
Valvular Insufficiency/ Regurgitation 2374 2830
Vascular Dissection 1622 5190
Aortic Valve Insufficiency/ Regurgitation 1609 3446
Heart Failure/Congestive Heart Failure 1562 2363
Hemorrhage/Bleeding 1420 8078
Dyspnea 1400 1400
Low Blood Pressure/ Hypotension 1236 1236
Obstruction/Occlusion 1219 4207
Rupture 1144 1453
Arrhythmia 875 7360
Complete Heart Block 847 847
Cardiac Arrest 822 6331
Thrombosis/Thrombus 762 3634
Myocardial Infarction 755 5175
Aortic Valve Stenosis 713 739
Injury 660 3986
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 646 9467
No Consequences Or Impact To Patient 619 619
Death 577 1568
Atrial Fibrillation 573 2967
No Known Impact Or Consequence To Patient 511 524
Pericardial Effusion 508 508
Endocarditis 501 3211
Cardiac Tamponade 492 615
Foreign Body In Patient 480 480
Cardiac Perforation 402 2362
Bradycardia 397 397
Cardiovascular Insufficiency 330 8006
Aortic Regurgitation 327 355
Renal Failure 314 893
Perforation of Vessels 285 350
Insufficiency, Valvular 282 282
Calcium Deposits/Calcification 275 275
Blood Loss 268 423
Perforation 259 2893
Hematoma 255 2908
Stenosis 250 250
Transient Ischemic Attack 246 3447
Chest Pain 238 238
Unspecified Vascular Problem 236 1378
Unspecified Infection 230 1104
Tachycardia 218 218
Ischemia Stroke 212 4215
Ventricular Fibrillation 210 210
No Code Available 200 303

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
4 Medtronic Heart Valves Division II Dec-10-2020
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