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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
2017 11 11
2018 51 51
2019 31 31
2020 220 289
2021 53 71

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 190 255
Insufficient Information 75 103
Perivalvular Leak 42 42
Malposition of Device 25 25
Incomplete Coaptation 17 17
Fluid Leak 17 17
Migration or Expulsion of Device 14 14
Appropriate Term/Code Not Available 14 14
Device Dislodged or Dislocated 12 12
Leak/Splash 12 12
Difficult to Remove 9 9
Material Rupture 8 8
Migration 8 8
Positioning Problem 6 6
Gradient Increase 6 6
Material Split, Cut or Torn 6 6
Burst Container or Vessel 5 5
Activation, Positioning or SeparationProblem 5 5
Obstruction of Flow 4 5
Degraded 4 4
Difficult To Position 3 3
Off-Label Use 3 3
Therapeutic or Diagnostic Output Failure 3 3
Entrapment of Device 3 3
Activation Failure 2 2
Physical Resistance/Sticking 2 2
Infusion or Flow Problem 2 2
Deflation Problem 2 2
Material Separation 2 2
Unintended Ejection 2 2
Calcified 1 1
Inflation Problem 1 1
Mechanical Problem 1 1
Device Slipped 1 1
Retraction Problem 1 1
Nonstandard Device 1 1
Gas Leak 1 1
Defective Device 1 1
Patient-Device Incompatibility 1 1
Deformation Due to Compressive Stress 1 1
Material Protrusion/Extrusion 1 1
Material Twisted/Bent 1 1
Protective Measures Problem 1 1
Torn Material 1 1
Patient Device Interaction Problem 1 1
Activation Problem 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Pacing Problem 1 1
Peeled/Delaminated 1 1
Failure to Advance 1 1
Difficult to Insert 1 1
Coagulation in Device or Device Ingredient 1 1
Failure to Conduct 1 1
Inadequacy of Device Shape and/or Size 1 1
Device Contamination with Body Fluid 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Injury 108 140
Death 56 76
Mitral Regurgitation 49 49
No Known Impact Or Consequence To Patient 29 29
No Code Available 26 33
Aortic Regurgitation 21 21
Obstruction/Occlusion 20 23
Vascular System (Circulation), Impaired 19 21
Insufficient Information 19 26
Infarction, Cerebral 17 26
Hemorrhage/Bleeding 14 14
Cardiac Perforation 13 15
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 12 27
Hematoma 10 12
Mitral Valve Stenosis 9 14
Regurgitation 9 9
Arrhythmia 9 11
Hemolysis 8 8
Perforation 8 9
Transient Ischemic Attack 7 7
Stenosis 7 7
Mitral Valve Insufficiency/ Regurgitation 7 9
Blood Loss 6 6
Stroke/CVA 6 8
Mitral Insufficiency 5 5
Thrombosis 5 5
Complete Heart Block 5 5
Unspecified Vascular Problem 4 5
Low Blood Pressure/ Hypotension 4 4
Failure of Implant 4 4
No Information 4 4
Heart Block 3 3
Aortic Insufficiency 3 3
Calcium Deposits/Calcification 3 3
Cardiopulmonary Arrest 3 3
Dyspnea 3 3
Vessel Or Plaque, Device Embedded In 2 2
Aortic Valve Stenosis 2 2
Cardiac Tamponade 2 3
Vascular Dissection 2 5
Thrombus 2 2
Occlusion 2 2
Regurgitation, Valvular 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Cardiogenic Shock 2 2
Ischemia Stroke 2 5
Foreign Body In Patient 2 2
Myocardial Infarction 2 2
Ventricular Fibrillation 2 2
Heart Failure 1 1
Tissue Damage 1 1
Therapeutic Response, Decreased 1 1
Hemolytic Anemia 1 1
Complaint, Ill-Defined 1 1
Cardiac Arrest 1 1
Unspecified Infection 1 1
Extubate 1 1
No Consequences Or Impact To Patient 1 1
Multiple Organ Failure 1 1
Heart Failure/Congestive Heart Failure 1 1
Valvular Insufficiency/ Regurgitation 1 1
Retroperitoneal Hemorrhage 1 1
Endocarditis 1 1
Fatigue 1 1
Congestive Heart Failure 1 1
Ischemia 1 5
Hemorrhage, Cerebral 1 3
High Blood Pressure/ Hypertension 1 1
Pulmonary Regurgitation 1 1
Rash 1 1
Renal Failure 1 1
Sepsis 1 1

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