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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)
2019 2020 2021 2022 2023 2024
0 0 0 0 0 1

MDR Year MDR Reports MDR Events
2019 30 30
2020 218 287
2021 248 339
2022 213 303
2023 288 449
2024 143 213

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 528 779
Insufficient Information 213 448
Perivalvular Leak 125 126
Malposition of Device 74 74
Fluid/Blood Leak 74 74
Migration or Expulsion of Device 33 33
Difficult to Open or Close 30 30
Gradient Increase 29 29
Migration 27 27
Degraded 25 25
Difficult to Remove 25 25
Burst Container or Vessel 23 23
Device Dislodged or Dislocated 22 22
Material Rupture 16 16
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 13 13
Incomplete Coaptation 12 12
Calcified 11 11
Difficult or Delayed Positioning 11 11
Device Stenosis 11 11
Material Deformation 10 10
Leak/Splash 10 10
Material Separation 9 9
Inflation Problem 7 7
Central Regurgitation 7 7
Positioning Problem 6 6
Patient Device Interaction Problem 5 5
Physical Resistance/Sticking 5 5
Therapeutic or Diagnostic Output Failure 4 4
Material Integrity Problem 4 4
Deflation Problem 4 4
Positioning Failure 3 3
Device Slipped 3 3
Off-Label Use 3 3
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Device Damaged by Another Device 3 3
Device-Device Incompatibility 3 3
Difficult to Advance 3 3
Thickening of Material 3 3
Activation Problem 2 2
Restricted Flow rate 2 2
Retraction Problem 2 2
Unintended Collision 2 2
Failure to Align 2 2
Entrapment of Device 2 2
Break 2 2
Fracture 2 2
Difficult to Insert 1 1
Mechanical Problem 1 1
Unintended Ejection 1 1
Coagulation in Device or Device Ingredient 1 1
Failure to Conduct 1 1
Failure to Advance 1 1
Deformation Due to Compressive Stress 1 1
Device Contamination with Body Fluid 1 1
Obstruction of Flow 1 2
Inadequacy of Device Shape and/or Size 1 1
Pacing Problem 1 1
Peeled/Delaminated 1 1
Misassembled 1 1
Material Puncture/Hole 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Unintended Movement 1 1
Misassembly by Users 1 1
Activation Failure 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 183 190
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 177 365
No Clinical Signs, Symptoms or Conditions 99 99
Injury 93 125
Mitral Valve Insufficiency/ Regurgitation 82 177
Obstruction/Occlusion 76 92
Cardiac Perforation 55 74
Death 49 69
Heart Block 41 87
Thrombosis/Thrombus 37 50
Ischemia Stroke 36 66
Mitral Regurgitation 36 36
Dyspnea 26 26
No Known Impact Or Consequence To Patient 26 26
Heart Failure/Congestive Heart Failure 24 24
Hemolysis 20 20
Vascular System (Circulation), Impaired 19 21
Infarction, Cerebral 17 26
Hemorrhage/Bleeding 16 18
Foreign Body In Patient 16 16
No Code Available 15 22
Hematoma 14 16
Mitral Valve Stenosis 12 17
Stroke/CVA 12 14
Perforation 11 12
Unspecified Vascular Problem 11 12
Vascular Dissection 11 23
Stenosis 10 10
Myocardial Infarction 9 9
Aortic Regurgitation 9 9
Arrhythmia 8 10
Endocarditis 7 7
Regurgitation 7 7
Cardiogenic Shock 7 7
Transient Ischemic Attack 7 7
Pericardial Effusion 7 7
Foreign Body Embolism 5 5
Complete Heart Block 5 5
Fatigue 5 5
Low Blood Pressure/ Hypotension 5 5
Failure of Implant 5 5
Mitral Insufficiency 4 4
Blood Loss 4 4
Perforation of Vessels 4 4
Rupture 4 4
Retroperitoneal Hemorrhage 4 4
Aortic Valve Insufficiency/ Regurgitation 3 3
Cardiac Tamponade 3 4
Cardiopulmonary Arrest 3 3
Calcium Deposits/Calcification 3 3
Aortic Valve Stenosis 3 3
Cardiac Arrest 2 2
Hemolytic Anemia 2 2
Ventricular Fibrillation 2 2
Thrombosis 2 2
Thrombus 2 2
Regurgitation, Valvular 2 2
Valvular Insufficiency/ Regurgitation 2 2
Cardiovascular Insufficiency 1 1
Pancreatitis 1 1
Swelling/ Edema 1 1
No Information 1 1
Mitral Perforation 1 1
Syncope/Fainting 1 1
Multiple Organ Failure 1 1
Tissue Damage 1 1
Dizziness 1 1
No Consequences Or Impact To Patient 1 1
Heart Failure 1 1
Complaint, Ill-Defined 1 1
Extubate 1 1
Coma 1 1
Atrial Fibrillation 1 1
Vessel Or Plaque, Device Embedded In 1 1
Anemia 1 1
Aortic Insufficiency 1 1
Chest Pain 1 1
Congestive Heart Failure 1 1
Hemorrhage, Cerebral 1 3
Ischemia 1 5
Laceration(s) 1 1
Occlusion 1 1
Rash 1 1
Renal Failure 1 1
Sepsis 1 1
Tachycardia 1 1

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