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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pulmonary valve prosthesis percutaneously delivered
Definition These devices are intended to replace a patient's pulmonary heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPV
Device Class Humanitarian Device Exemption

Premarket Approvals (PMA)
2017 2018 2019 2020 2021 2022
5 2 4 7 16 2

MDR Year MDR Reports MDR Events
2017 96 96
2018 129 129
2019 144 144
2020 115 115
2021 160 160

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 179 179
Adverse Event Without Identified Device or Use Problem 134 134
Gradient Increase 113 113
Fracture 108 108
Obstruction of Flow 38 38
Perivalvular Leak 36 36
Malposition of Device 34 34
Device Dislodged or Dislocated 32 32
Incomplete Coaptation 25 25
Fluid Leak 22 22
Calcified 20 20
Patient Device Interaction Problem 16 16
Migration 15 15
Appropriate Term/Code Not Available 15 15
Degraded 14 14
Migration or Expulsion of Device 13 13
Material Rupture 12 12
Burst Container or Vessel 12 12
Inadequacy of Device Shape and/or Size 10 10
Material Separation 8 8
Inflation Problem 8 8
Positioning Problem 8 8
Material Deformation 8 8
Activation Failure 6 6
No Apparent Adverse Event 6 6
Deflation Problem 6 6
Partial Blockage 6 6
Leak/Splash 5 5
Material Split, Cut or Torn 5 5
Difficult to Remove 5 5
Difficult to Advance 4 4
Mechanical Problem 4 4
Complete Blockage 4 4
Off-Label Use 4 4
Structural Problem 4 4
Occlusion Within Device 3 3
Difficult or Delayed Positioning 3 3
Material Integrity Problem 3 3
Activation, Positioning or SeparationProblem 3 3
Failure to Advance 3 3
Torn Material 3 3
Unintended Movement 3 3
Deformation Due to Compressive Stress 2 2
Bent 2 2
Device Slipped 2 2
Use of Device Problem 2 2
Material Perforation 1 1
Failure to Deliver 1 1
Failure to Align 1 1
Peeled/Delaminated 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1
Reflux within Device 1 1
Backflow 1 1
Positioning Failure 1 1
Crack 1 1
Material Invagination 1 1
Material Fragmentation 1 1
Device-Device Incompatibility 1 1
Split 1 1
Biocompatibility 1 1
Naturally Worn 1 1
Material Distortion 1 1
Difficult to Open or Close 1 1
Improper Flow or Infusion 1 1
Thickening of Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pulmonary Valve Stenosis 95 95
No Known Impact Or Consequence To Patient 95 95
Endocarditis 91 91
No Information 82 82
Insufficient Information 60 60
Stenosis 55 55
Pulmonary Regurgitation 55 55
Pulmonary Valve Insufficiency/ Regurgitation 37 37
Injury 34 34
Obstruction/Occlusion 27 27
No Clinical Signs, Symptoms or Conditions 26 26
Vascular System (Circulation), Impaired 21 21
No Consequences Or Impact To Patient 20 20
Regurgitation, Valvular 19 19
Mitral Regurgitation 19 19
No Code Available 18 18
Thrombus 17 17
Non specific EKG/ECG Changes 15 15
Death 15 15
Insufficiency, Valvular 14 14
Pulmonary Insufficiency 13 13
Hemorrhage/Bleeding 13 13
Blood Loss 13 13
Rupture 13 13
Calcium Deposits/Calcification 12 12
Aortic Regurgitation 12 12
Mitral Valve Stenosis 12 12
Tricuspid Regurgitation 12 12
High Blood Pressure/ Hypertension 10 10
Aortic Valve Stenosis 10 10
Thrombosis/Thrombus 10 10
Pseudoaneurysm 9 9
Regurgitation 9 9
Corneal Pannus 9 9
Stroke/CVA 9 9
Unspecified Infection 8 8
Ventricular Tachycardia 8 8
Pulmonary Edema 7 7
Arrhythmia 7 7
Valvular Insufficiency/ Regurgitation 7 7
Heart Failure/Congestive Heart Failure 6 6
Low Cardiac Output 6 6
Vascular Dissection 6 6
Cardiac Arrest 6 6
Congestive Heart Failure 6 6
Fatigue 6 6
Occlusion 6 6
Failure of Implant 6 6
Right Ventricular Dysfunction 6 6
Tachycardia 5 5
Fistula 5 5
Hematoma 5 5
Valvular Stenosis 5 5
Complete Heart Block 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Heart Block 4 4
Cardiovascular Insufficiency 4 4
Dyspnea 4 4
Pulmonary Embolism 4 4
Sepsis 4 4
Mitral Insufficiency 4 4
Low Blood Pressure/ Hypotension 4 4
Perforation 4 4
Pulmonary Dysfunction 3 3
Right Ventricular Hypertrophy 3 3
Tricuspid Insufficiency 3 3
Ventricular Fibrillation 3 3
Bradycardia 3 3
Embolism 3 3
Pericardial Effusion 3 3
Heart Failure 3 3
Unspecified Heart Problem 3 3
Respiratory Insufficiency 3 3
Unspecified Tissue Injury 3 3
Aortic Valve Insufficiency/ Regurgitation 2 2
Cardiac Perforation 2 2
Great Vessel Perforation 2 2
Respiratory Failure 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Patient Problem/Medical Problem 2 2
Fever 2 2
Host-Tissue Reaction 2 2
Chest Pain 2 2
Congenital Defect/Deformity 2 2
Aneurysm 2 2
Atrial Fibrillation 2 2
Tricuspid Valve Stenosis 2 2
Pleural Effusion 2 2
Myocardial Infarction 2 2
Inflammation 2 2
Ischemia 2 2
Left Ventricular Failure 1 1
Left Ventricular Hypertrophy 1 1
Idioventricular Rhythm 1 1
Vasodilatation 1 1
Tissue Damage 1 1
Perforation of Vessels 1 1
Thrombosis 1 1

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