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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device prosthesis, mitral valve, percutaneously delivered
Definition These devices are intended to replace a patient's mitral heart valve. They are different from the classified device (heart valves) in that they are placed percutaniously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPU
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
0 0 0 0 1 1

MDR Year MDR Reports MDR Events
2020 218 287
2021 248 339
2022 213 303
2023 288 449
2024 280 419
2025 133 221

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 618 943
Insufficient Information 265 583
Perivalvular Leak 142 143
Malposition of Device 87 87
Fluid/Blood Leak 84 84
Difficult to Open or Close 40 40
Gradient Increase 38 38
Migration or Expulsion of Device 37 37
Degraded 37 37
Burst Container or Vessel 32 32
Migration 31 31
Device Stenosis 30 30
Difficult to Remove 27 27
Device Dislodged or Dislocated 22 22
Calcified 19 19
Central Regurgitation 18 18
Material Deformation 14 14
Material Split, Cut or Torn 14 14
Difficult or Delayed Positioning 12 12
Material Rupture 11 11
Incomplete Coaptation 11 11
Material Separation 9 9
Inflation Problem 9 9
Leak/Splash 8 8
Appropriate Term/Code Not Available 8 8
Patient Device Interaction Problem 8 8
Device Slipped 6 6
Physical Resistance/Sticking 6 6
Difficult to Insert 6 6
Thickening of Material 5 5
Detachment of Device or Device Component 4 4
Device Damaged by Another Device 4 4
Deflation Problem 4 4
Positioning Problem 4 4
Material Integrity Problem 4 4
Difficult to Advance 4 4
Positioning Failure 3 3
Therapeutic or Diagnostic Output Failure 3 3
Patient-Device Incompatibility 3 3
Off-Label Use 3 3
Device-Device Incompatibility 3 3
Failure to Advance 2 2
Fracture 2 2
Unintended Collision 2 2
Retraction Problem 2 2
Failure to Align 2 2
Material Fragmentation 2 2
Restricted Flow rate 2 2
Activation Problem 2 2
Break 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 239 246
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 225 482
No Clinical Signs, Symptoms or Conditions 137 137
Mitral Valve Insufficiency/ Regurgitation 100 236
Obstruction/Occlusion 89 110
Injury 84 116
Cardiac Perforation 72 100
Heart Block 55 119
Thrombosis/Thrombus 49 63
Ischemia Stroke 47 91
Death 47 67
Heart Failure/Congestive Heart Failure 44 44
Dyspnea 43 43
Hemolysis 24 24
Mitral Regurgitation 23 23
Stroke/CVA 18 20
Vascular System (Circulation), Impaired 18 20
Infarction, Cerebral 17 26
Foreign Body In Patient 16 16
No Known Impact Or Consequence To Patient 16 16
Hemorrhage/Bleeding 15 17
Hematoma 14 16
No Code Available 13 20
Unspecified Vascular Problem 12 13
Perforation 12 13
Vascular Dissection 11 23
Myocardial Infarction 10 10
Mitral Valve Stenosis 9 14
Low Blood Pressure/ Hypotension 8 8
Pericardial Effusion 8 8
Arrhythmia 8 10
Transient Ischemic Attack 7 7
Fatigue 7 7
Endocarditis 7 7
Foreign Body Embolism 7 7
Cardiogenic Shock 7 7
Stenosis 6 6
Complete Heart Block 5 5
Aortic Regurgitation 5 5
Failure of Implant 5 5
Perforation of Vessels 4 4
Rupture 4 4
Cardiac Tamponade 4 5
Retroperitoneal Hemorrhage 4 4
Blood Loss 3 3
Atrial Fibrillation 3 3
Anemia 3 3
Calcium Deposits/Calcification 3 3
Hemolytic Anemia 3 3
Cardiac Arrest 3 3

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