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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
2018 51 51
2019 31 31
2020 220 289
2021 250 341
2022 217 307

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 379 525
Insufficient Information 143 252
Perivalvular Leak 90 91
Malposition of Device 51 51
Fluid/Blood Leak 42 42
Migration or Expulsion of Device 22 22
Device Dislodged or Dislocated 20 20
Difficult to Remove 18 18
Migration 16 16
Incomplete Coaptation 16 16
Appropriate Term/Code Not Available 15 15
Gradient Increase 15 15
Burst Container or Vessel 15 15
Material Split, Cut or Torn 13 13
Leak/Splash 12 12
Degraded 11 11
Material Rupture 11 11
Difficult to Open or Close 8 8
Positioning Problem 7 7
Material Separation 7 7
Calcified 5 5
Difficult or Delayed Positioning 5 5
Activation, Positioning or Separation Problem 5 5
Obstruction of Flow 4 5
Therapeutic or Diagnostic Output Failure 4 4
Material Deformation 4 4
Physical Resistance/Sticking 4 4
Material Integrity Problem 3 3
Off-Label Use 3 3
Inflation Problem 3 3
Difficult To Position 3 3
Entrapment of Device 3 3
Activation Failure 2 2
Retraction Problem 2 2
Detachment of Device or Device Component 2 2
Unintended Ejection 2 2
Break 2 2
Deflation Problem 2 2
Infusion or Flow Problem 2 2
Failure to Advance 2 2
Device-Device Incompatibility 1 1
Peeled/Delaminated 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Contamination with Body Fluid 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Protective Measures Problem 1 1
Patient Device Interaction Problem 1 1
Positioning Failure 1 1
Fracture 1 1
Patient-Device Incompatibility 1 1
Gas/Air Leak 1 1
Mechanical Problem 1 1
Nonstandard Device 1 1
Device Slipped 1 1
Failure to Align 1 1
Defective Device 1 1
Deformation Due to Compressive Stress 1 1
Torn Material 1 1
Activation Problem 1 1
Difficult to Advance 1 1
Restricted Flow rate 1 1
Difficult to Insert 1 1
Pacing Problem 1 1
Coagulation in Device or Device Ingredient 1 1
Failure to Conduct 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 104 136
Insufficient Information 93 100
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 91 184
Death 55 75
No Clinical Signs, Symptoms or Conditions 53 53
Mitral Valve Insufficiency/ Regurgitation 50 83
Obstruction/Occlusion 50 55
Mitral Regurgitation 48 48
Cardiac Perforation 42 48
No Known Impact Or Consequence To Patient 29 29
No Code Available 25 32
Thrombosis/Thrombus 23 29
Heart Block 21 44
Vascular System (Circulation), Impaired 19 21
Hemorrhage/Bleeding 18 20
Infarction, Cerebral 17 26
Aortic Regurgitation 17 17
Ischemia Stroke 15 26
Hematoma 14 16
Hemolysis 12 12
Mitral Valve Stenosis 11 16
Heart Failure/Congestive Heart Failure 10 10
Vascular Dissection 9 21
Perforation 9 10
Arrhythmia 9 11
Stroke/CVA 9 11
Regurgitation 9 9
Dyspnea 8 8
Cardiogenic Shock 8 8
Stenosis 8 8
Unspecified Vascular Problem 7 8
Transient Ischemic Attack 7 7
Foreign Body In Patient 7 7
Low Blood Pressure/ Hypotension 6 6
Blood Loss 6 6
Thrombosis 5 5
Complete Heart Block 5 5
Retroperitoneal Hemorrhage 4 4
No Information 4 4
Myocardial Infarction 4 4
Mitral Insufficiency 4 4
Pericardial Effusion 4 4
Failure of Implant 4 4
Calcium Deposits/Calcification 3 3
Cardiopulmonary Arrest 3 3
Perforation of Vessels 3 3
Rupture 3 3
Endocarditis 3 3
Occlusion 2 2
Cardiac Tamponade 2 3
Regurgitation, Valvular 2 2
Vessel Or Plaque, Device Embedded In 2 2
Aortic Insufficiency 2 2
Aortic Valve Stenosis 2 2
Fatigue 2 2
Foreign Body Embolism 2 2
Thrombus 2 2
Ventricular Fibrillation 2 2
Atrial Fibrillation 1 1
Cardiac Arrest 1 1
Unspecified Infection 1 1
Hemolytic Anemia 1 1
Complaint, Ill-Defined 1 1
Mitral Perforation 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
High Blood Pressure/ Hypertension 1 1
Ischemia 1 5
Congestive Heart Failure 1 1
No Consequences Or Impact To Patient 1 1
Rash 1 1
Sepsis 1 1
Pulmonary Regurgitation 1 1
Renal Failure 1 1
Hemorrhage, Cerebral 1 3
Multiple Organ Failure 1 1
Valvular Insufficiency/ Regurgitation 1 1
Extubate 1 1
Tissue Damage 1 1
Heart Failure 1 1
Therapeutic Response, Decreased 1 1

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