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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)
2020 2021 2022 2023 2024 2025
7 16 26 36 19 0

MDR Year MDR Reports MDR Events
2020 112 112
2021 153 153
2022 191 191
2023 253 253
2024 326 326
2025 40 40

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 247 247
Patient Device Interaction Problem 156 156
Adverse Event Without Identified Device or Use Problem 151 151
Fracture 133 133
Gradient Increase 114 114
Fluid/Blood Leak 76 76
Central Regurgitation 72 72
Degraded 60 60
Perivalvular Leak 54 54
Device Stenosis 53 53
Malposition of Device 41 41
Burst Container or Vessel 30 30
Device Dislodged or Dislocated 28 28
Migration 28 28
Difficult to Open or Close 26 26
Material Separation 23 23
Structural Problem 21 21
Difficult to Remove 18 18
Difficult or Delayed Positioning 18 18
Migration or Expulsion of Device 17 17
Activation Failure 17 17
Incomplete Coaptation 16 16
Thickening of Material 16 16
Inadequacy of Device Shape and/or Size 15 15
Appropriate Term/Code Not Available 15 15
Calcified 15 15
Difficult to Advance 14 14
Material Deformation 14 14
No Apparent Adverse Event 11 11
Material Split, Cut or Torn 10 10
Partial Blockage 8 8
Material Rupture 6 6
Device Damaged by Another Device 6 6
Deformation Due to Compressive Stress 6 6
Inflation Problem 6 6
Obstruction of Flow 6 6
Material Invagination 5 5
Deflation Problem 5 5
Detachment of Device or Device Component 5 5
Patient-Device Incompatibility 4 4
Mechanical Problem 4 4
Material Integrity Problem 3 3
Backflow 3 3
Reflux within Device 3 3
Device Slipped 3 3
Positioning Failure 2 2
Positioning Problem 2 2
Physical Resistance/Sticking 2 2
Packaging Problem 2 2
Off-Label Use 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 361 361
No Clinical Signs, Symptoms or Conditions 245 245
Pulmonary Valve Stenosis 103 103
Pulmonary Valve Insufficiency/ Regurgitation 102 102
Endocarditis 96 96
Non specific EKG/ECG Changes 59 59
Obstruction/Occlusion 43 43
Valvular Insufficiency/ Regurgitation 43 43
Tachycardia 37 37
Thrombosis/Thrombus 37 37
Dyspnea 37 37
Hemorrhage/Bleeding 29 29
Heart Failure/Congestive Heart Failure 25 25
No Information 22 22
Tricuspid Valve Insufficiency/ Regurgitation 22 22
Cardiovascular Insufficiency 19 19
Chest Pain 19 19
Arrhythmia 18 18
Stenosis 17 17
Fever 16 16
Cardiac Arrest 16 16
Heart Block 15 15
Rupture 14 14
Mitral Valve Stenosis 13 13
Sepsis 13 13
Fatigue 13 13
Unspecified Infection 12 12
No Consequences Or Impact To Patient 11 11
Low Blood Pressure/ Hypotension 10 10
No Known Impact Or Consequence To Patient 10 10
Pulmonary Regurgitation 10 10
Ventricular Fibrillation 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Pulmonary Edema 8 8
Valvular Stenosis 8 8
Unspecified Tissue Injury 8 8
Bacterial Infection 8 8
High Blood Pressure/ Hypertension 7 7
Hematoma 7 7
Aortic Valve Insufficiency/ Regurgitation 7 7
Stroke/CVA 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 7 7
Foreign Body In Patient 7 7
Great Vessel Perforation 7 7
Vascular Dissection 6 6
Bradycardia 6 6
Injury 6 6
Pulmonary Embolism 5 5
Cardiac Tamponade 5 5
Death 5 5

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