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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)
2019 2020 2021 2022 2023 2024
4 7 16 26 36 11

MDR Year MDR Reports MDR Events
2019 143 143
2020 112 112
2021 153 153
2022 191 191
2023 253 253
2024 80 80

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 237 237
Adverse Event Without Identified Device or Use Problem 158 158
Fracture 130 130
Gradient Increase 123 123
Fluid/Blood Leak 66 66
Patient Device Interaction Problem 66 66
Perivalvular Leak 54 54
Malposition of Device 44 44
Degraded 42 42
Burst Container or Vessel 28 28
Obstruction of Flow 28 28
Central Regurgitation 27 27
Device Stenosis 26 26
Migration 26 26
Material Separation 24 24
Device Dislodged or Dislocated 23 23
Incomplete Coaptation 22 22
Difficult to Open or Close 21 21
Material Deformation 16 16
Difficult to Remove 16 16
Inadequacy of Device Shape and/or Size 14 14
Calcified 14 14
Migration or Expulsion of Device 13 13
Partial Blockage 11 11
No Apparent Adverse Event 11 11
Appropriate Term/Code Not Available 10 10
Difficult to Advance 10 10
Material Rupture 10 10
Structural Problem 10 10
Material Split, Cut or Torn 9 9
Difficult or Delayed Positioning 7 7
Inflation Problem 7 7
Activation Failure 6 6
Device Damaged by Another Device 6 6
Thickening of Material 5 5
Deflation Problem 5 5
Material Invagination 4 4
Leak/Splash 4 4
Mechanical Problem 4 4
Deformation Due to Compressive Stress 4 4
Patient-Device Incompatibility 4 4
Material Integrity Problem 4 4
Positioning Problem 3 3
Unintended Movement 3 3
Backflow 3 3
Reflux within Device 3 3
Off-Label Use 3 3
Unintended Collision 2 2
Device Slipped 2 2
Break 2 2
Complete Blockage 2 2
Positioning Failure 2 2
Material Twisted/Bent 2 2
Activation, Positioning or Separation Problem 2 2
Detachment of Device or Device Component 2 2
Device-Device Incompatibility 2 2
Physical Resistance/Sticking 2 2
Activation Problem 1 1
Patient Data Problem 1 1
Biocompatibility 1 1
Failure to Align 1 1
Failure to Advance 1 1
Material Fragmentation 1 1
Crack 1 1
Use of Device Problem 1 1
Material Perforation 1 1
Failure to Deliver 1 1
Material Puncture/Hole 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 286 286
No Clinical Signs, Symptoms or Conditions 155 155
Pulmonary Valve Stenosis 108 108
Endocarditis 91 91
Pulmonary Valve Insufficiency/ Regurgitation 85 85
No Information 57 57
No Known Impact Or Consequence To Patient 42 42
Obstruction/Occlusion 36 36
Stenosis 34 34
Non specific EKG/ECG Changes 34 34
Pulmonary Regurgitation 30 30
Valvular Insufficiency/ Regurgitation 28 28
Thrombosis/Thrombus 26 26
Hemorrhage/Bleeding 23 23
Dyspnea 23 23
Tachycardia 21 21
No Consequences Or Impact To Patient 19 19
Heart Failure/Congestive Heart Failure 18 18
Rupture 16 16
Injury 14 14
Tricuspid Valve Insufficiency/ Regurgitation 14 14
Vascular System (Circulation), Impaired 14 14
Arrhythmia 14 14
Cardiac Arrest 14 14
Mitral Valve Stenosis 14 14
Chest Pain 13 13
Fatigue 13 13
Cardiovascular Insufficiency 13 13
Regurgitation, Valvular 11 11
Insufficiency, Valvular 11 11
Fever 10 10
Death 10 10
Heart Block 10 10
Blood Loss 10 10
Stroke/CVA 9 9
Mitral Regurgitation 9 9
High Blood Pressure/ Hypertension 9 9
Low Blood Pressure/ Hypotension 8 8
Unspecified Infection 8 8
Pulmonary Insufficiency 8 8
Valvular Stenosis 8 8
Thrombus 8 8
Sepsis 7 7
Ventricular Fibrillation 7 7
Vascular Dissection 7 7
No Code Available 7 7
Hematoma 7 7
Bacterial Infection 7 7
Pulmonary Embolism 6 6
Aortic Regurgitation 6 6
Aortic Valve Stenosis 6 6
Foreign Body In Patient 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Aortic Valve Insufficiency/ Regurgitation 5 5
Mitral Valve Insufficiency/ Regurgitation 5 5
Pseudoaneurysm 5 5
Low Cardiac Output 5 5
Pulmonary Edema 5 5
Right Ventricular Dysfunction 5 5
Failure of Implant 4 4
Bradycardia 4 4
Fistula 4 4
Cardiac Tamponade 4 4
Tricuspid Regurgitation 4 4
Renal Failure 4 4
Unspecified Tissue Injury 4 4
Unspecified Heart Problem 4 4
Unspecified Vascular Problem 3 3
Complete Heart Block 3 3
Thromboembolism 3 3
Cusp Tear 3 3
Pericardial Effusion 3 3
Embolism/Embolus 3 3
Tricuspid Insufficiency 3 3
Ventricular Tachycardia 3 3
Vomiting 3 3
Regurgitation 3 3
Congestive Heart Failure 3 3
Calcium Deposits/Calcification 3 3
Atrial Fibrillation 3 3
Abscess 3 3
Hemolysis 3 3
Occlusion 3 3
Perforation 3 3
Respiratory Insufficiency 3 3
Pleural Effusion 2 2
Myocardial Infarction 2 2
Nausea 2 2
Pulmonary Dysfunction 2 2
Hemoptysis 2 2
Hemothorax 2 2
Inflammation 2 2
Anemia 2 2
Erosion 2 2
Cardiogenic Shock 2 2
Cardiac Perforation 2 2
Respiratory Failure 2 2
Great Vessel Perforation 2 2
Heart Failure 2 2
Perforation of Vessels 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc I Apr-18-2022
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