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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device system, appendage closure, left atrial
Product CodeNGV
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
10 5 10 9 10 5

MDR Year MDR Reports MDR Events
2019 996 996
2020 935 935
2021 1175 1175
2022 1493 1493
2023 2430 3397
2024 1473 11016

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5973 14631
Difficult to Open or Close 518 1136
Device Dislodged or Dislocated 422 454
Migration 347 420
Material Deformation 332 332
Migration or Expulsion of Device 233 264
Material Integrity Problem 195 195
Patient Device Interaction Problem 166 896
Difficult to Remove 165 165
Patient-Device Incompatibility 155 155
Detachment of Device or Device Component 105 105
Improper or Incorrect Procedure or Method 51 51
Gas/Air Leak 42 42
Use of Device Problem 39 39
Leak/Splash 38 38
Insufficient Information 36 134
Difficult to Fold, Unfold or Collapse 30 30
Air/Gas in Device 26 26
No Apparent Adverse Event 16 286
Difficult to Advance 15 15
Premature Separation 14 14
Difficult to Flush 14 14
Biocompatibility 11 11
Positioning Problem 11 11
Contamination /Decontamination Problem 10 10
Device-Device Incompatibility 10 10
Malposition of Device 10 10
Difficult or Delayed Positioning 10 10
Defective Device 8 8
Device Contamination with Chemical or Other Material 8 8
Material Protrusion/Extrusion 7 7
Physical Resistance/Sticking 7 7
Fracture 7 7
Activation Failure 6 6
Separation Problem 4 4
Contamination 4 4
Fluid/Blood Leak 4 4
Positioning Failure 4 4
Activation, Positioning or Separation Problem 4 4
Separation Failure 3 3
Inadequacy of Device Shape and/or Size 3 3
Difficult to Insert 3 3
Device Difficult to Setup or Prepare 3 3
Therapeutic or Diagnostic Output Failure 3 3
Output Problem 2 2
Appropriate Term/Code Not Available 2 2
Activation Problem 2 2
Off-Label Use 2 2
Entrapment of Device 2 2
Break 2 2
Obstruction of Flow 2 2
Device Damaged by Another Device 2 2
Device Markings/Labelling Problem 1 1
Failure to Capture 1 1
Product Quality Problem 1 1
Retraction Problem 1 1
Loose or Intermittent Connection 1 1
Premature Activation 1 1
Material Twisted/Bent 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pericardial Effusion 2116 3785
No Clinical Signs, Symptoms or Conditions 1842 4379
Thrombosis/Thrombus 1418 2605
Stroke/CVA 825 2156
Cardiac Tamponade 673 1053
Low Blood Pressure/ Hypotension 556 556
Cardiac Perforation 496 496
Thrombosis 430 430
No Consequences Or Impact To Patient 344 344
Transient Ischemic Attack 237 863
Cardiac Arrest 222 388
Hemorrhage/Bleeding 214 570
Insufficient Information 176 1170
Death 153 153
Air Embolism 133 153
Dyspnea 132 132
Hematoma 132 733
Chest Pain 122 122
Non specific EKG/ECG Changes 83 83
Angina 80 80
Perforation of Vessels 80 167
No Code Available 80 80
Pseudoaneurysm 69 173
Myocardial Infarction 69 154
Perforation 67 67
Heart Failure/Congestive Heart Failure 67 126
Pericarditis 67 133
Bradycardia 54 54
Tachycardia 52 52
Thromboembolism 44 155
Arrhythmia 41 41
Obstruction/Occlusion 40 40
Atrial Fibrillation 39 39
Retroperitoneal Hemorrhage 39 69
Fistula 38 51
Endocarditis 36 71
Unspecified Infection 36 62
Pain 35 35
ST Segment Elevation 32 32
Pleural Effusion 30 43
Pulmonary Embolism 29 46
Embolism/Embolus 28 30
Unspecified Tissue Injury 27 27
Muscle Weakness 27 27
Intracranial Hemorrhage 26 117
Blood Loss 23 23
High Blood Pressure/ Hypertension 20 20
Respiratory Insufficiency 20 43
Speech Disorder 20 20
No Known Impact Or Consequence To Patient 19 19
Sepsis 18 18
Ventricular Fibrillation 16 16
Dizziness 16 16
Fatigue 16 16
Fever 15 15
Hypoxia 14 14
Renal Failure 14 14
Mitral Valve Insufficiency/ Regurgitation 14 14
Foreign Body In Patient 13 13
Hypersensitivity/Allergic reaction 13 13
Paralysis 13 13
Loss of Vision 12 12
Heart Block 12 12
Swelling/ Edema 12 12
Pneumonia 11 11
Injury 11 11
Headache 11 11
Nausea 10 10
Numbness 10 10
Dysphasia 10 10
Gastrointestinal Hemorrhage 10 10
Syncope/Fainting 10 10
Asystole 9 9
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 9 9
Vomiting 9 9
Vascular Dissection 9 9
Cardiogenic Shock 8 8
Inflammation 8 8
Mitral Insufficiency 8 8
Bacterial Infection 8 8
Unspecified Heart Problem 8 8
Failure of Implant 7 7
Tissue Damage 7 7
Weakness 7 7
Pneumothorax 7 10
Ventricular Tachycardia 7 7
Blurred Vision 6 6
Convulsion/Seizure 6 6
Cognitive Changes 6 6
Confusion/ Disorientation 6 6
Loss of consciousness 6 6
Hemothorax 6 6
Anemia 6 6
Hemoptysis 5 5
Ischemia 5 5
No Patient Involvement 5 5
Shock 5 5
Pulmonary Edema 4 4
Septic Shock 4 4
Diminished Pulse Pressure 4 4

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