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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

MDR Year MDR Reports MDR Events
2019 30 30
2020 218 287
2021 248 339
2022 213 303
2023 288 449
2024 60 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 499 738
Insufficient Information 201 409
Perivalvular Leak 119 120
Malposition of Device 70 70
Fluid/Blood Leak 69 69
Migration or Expulsion of Device 30 30
Difficult to Open or Close 28 28
Gradient Increase 26 26
Migration 24 24
Difficult to Remove 23 23
Burst Container or Vessel 21 21
Device Dislodged or Dislocated 21 21
Degraded 20 20
Material Rupture 16 16
Appropriate Term/Code Not Available 13 13
Material Split, Cut or Torn 13 13
Incomplete Coaptation 11 11
Leak/Splash 10 10
Material Separation 9 9
Material Deformation 9 9
Device Stenosis 8 8
Difficult or Delayed Positioning 8 8
Calcified 8 8
Positioning Problem 6 6
Central Regurgitation 5 5
Inflation Problem 5 5
Patient Device Interaction Problem 4 4
Physical Resistance/Sticking 4 4
Therapeutic or Diagnostic Output Failure 4 4
Material Integrity Problem 3 3
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Device Damaged by Another Device 3 3
Thickening of Material 3 3
Deflation Problem 3 3
Positioning Failure 3 3
Device Slipped 3 3
Off-Label Use 3 3
Retraction Problem 2 2
Unintended Collision 2 2
Failure to Align 2 2
Entrapment of Device 2 2
Break 2 2
Fracture 2 2
Activation Problem 2 2
Restricted Flow rate 2 2
Device-Device Incompatibility 2 2
Difficult to Advance 2 2
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Unintended Movement 1 1
Activation Failure 1 1
Infusion or Flow Problem 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 164 171
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 160 330
No Clinical Signs, Symptoms or Conditions 93 93
Injury 93 125
Mitral Valve Insufficiency/ Regurgitation 77 159
Obstruction/Occlusion 68 83
Cardiac Perforation 54 71
Death 49 69
Heart Block 37 82
Mitral Regurgitation 36 36
Thrombosis/Thrombus 35 46
Ischemia Stroke 33 61
No Known Impact Or Consequence To Patient 26 26
Dyspnea 21 21
Hemolysis 20 20
Vascular System (Circulation), Impaired 19 21
Heart Failure/Congestive Heart Failure 19 19
Infarction, Cerebral 17 26
Hemorrhage/Bleeding 15 17
No Code Available 15 22
Hematoma 14 16
Foreign Body In Patient 14 14
Mitral Valve Stenosis 12 17
Stroke/CVA 12 14
Vascular Dissection 11 23
Unspecified Vascular Problem 11 12
Perforation 10 11
Aortic Regurgitation 9 9
Stenosis 9 9
Arrhythmia 8 10
Endocarditis 7 7
Myocardial Infarction 7 7
Regurgitation 7 7
Cardiogenic Shock 7 7
Transient Ischemic Attack 7 7
Pericardial Effusion 6 6
Complete Heart Block 5 5
Low Blood Pressure/ Hypotension 5 5
Mitral Insufficiency 4 4
Blood Loss 4 4
Perforation of Vessels 4 4
Rupture 4 4
Retroperitoneal Hemorrhage 4 4
Cardiac Tamponade 3 4
Foreign Body Embolism 3 3
Failure of Implant 3 3
Fatigue 3 3
Cardiopulmonary Arrest 3 3
Calcium Deposits/Calcification 3 3
Aortic Valve Stenosis 3 3
Cardiac Arrest 2 2
Regurgitation, Valvular 2 2
Ventricular Fibrillation 2 2
Thrombosis 2 2
Thrombus 2 2
Hemolytic Anemia 2 2
Aortic Valve Insufficiency/ Regurgitation 2 2
Valvular Insufficiency/ Regurgitation 1 1
Swelling/ Edema 1 1
Pancreatitis 1 1
Complaint, Ill-Defined 1 1
Mitral Perforation 1 1
Extubate 1 1
Coma 1 1
Tissue Damage 1 1
No Consequences Or Impact To Patient 1 1
Heart Failure 1 1
No Information 1 1
Multiple Organ Failure 1 1
Syncope/Fainting 1 1
Cardiovascular Insufficiency 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
Ischemia 1 5
Laceration(s) 1 1
Hemorrhage, Cerebral 1 3
Occlusion 1 1
Rash 1 1
Renal Failure 1 1
Sepsis 1 1

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