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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 2

MDR Year MDR Reports MDR Events
2019 996 996
2020 935 935
2021 1175 1175
2022 1493 1493
2023 2430 3397
2024 1041 9722

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 5721 13820
Difficult to Open or Close 472 1090
Device Dislodged or Dislocated 404 436
Migration 321 394
Material Deformation 317 317
Migration or Expulsion of Device 211 222
Material Integrity Problem 188 188
Difficult to Remove 159 159
Patient Device Interaction Problem 147 640
Patient-Device Incompatibility 130 130
Detachment of Device or Device Component 102 102
Gas/Air Leak 42 42
Improper or Incorrect Procedure or Method 41 41
Use of Device Problem 37 37
Leak/Splash 36 36
Insufficient Information 33 85
Difficult to Fold, Unfold or Collapse 30 30
Air/Gas in Device 21 21
Difficult to Advance 15 15
No Apparent Adverse Event 15 285
Premature Separation 13 13
Difficult to Flush 13 13
Biocompatibility 11 11
Malposition of Device 10 10
Difficult or Delayed Positioning 10 10
Positioning Problem 10 10
Contamination /Decontamination Problem 9 9
Device-Device Incompatibility 9 9
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
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
Appropriate Term/Code Not Available 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 2008 3557
No Clinical Signs, Symptoms or Conditions 1723 4260
Thrombosis/Thrombus 1318 2434
Stroke/CVA 785 2074
Cardiac Tamponade 625 955
Low Blood Pressure/ Hypotension 527 527
Cardiac Perforation 478 478
Thrombosis 430 430
No Consequences Or Impact To Patient 344 344
Transient Ischemic Attack 221 829
Cardiac Arrest 211 367
Hemorrhage/Bleeding 186 481
Death 153 153
Insufficient Information 152 775
Air Embolism 129 149
Hematoma 125 665
Chest Pain 115 115
Dyspnea 113 113
No Code Available 80 80
Perforation of Vessels 78 165
Non specific EKG/ECG Changes 75 75
Angina 70 70
Pseudoaneurysm 65 169
Myocardial Infarction 63 120
Pericarditis 61 107
Heart Failure/Congestive Heart Failure 56 99
Perforation 55 55
Tachycardia 49 49
Bradycardia 49 49
Thromboembolism 40 151
Retroperitoneal Hemorrhage 39 69
Arrhythmia 38 38
Atrial Fibrillation 36 36
Fistula 36 49
Unspecified Infection 35 50
Obstruction/Occlusion 34 34
Pain 33 33
ST Segment Elevation 32 32
Endocarditis 31 66
Pleural Effusion 26 34
Pulmonary Embolism 25 34
Muscle Weakness 23 23
Blood Loss 23 23
Intracranial Hemorrhage 21 30
Embolism/Embolus 20 22
Unspecified Tissue Injury 19 19
No Known Impact Or Consequence To Patient 19 19
High Blood Pressure/ Hypertension 18 18
Sepsis 17 17
Respiratory Insufficiency 16 30
Speech Disorder 16 16
Dizziness 15 15
Fatigue 15 15
Ventricular Fibrillation 13 13
Renal Failure 13 13
Foreign Body In Patient 13 13
Fever 12 12
Hypersensitivity/Allergic reaction 12 12
Headache 11 11
Paralysis 11 11
Injury 11 11
Loss of Vision 11 11
Heart Block 11 11
Mitral Valve Insufficiency/ Regurgitation 10 10
Swelling/ Edema 10 10
Pneumonia 10 10
Numbness 10 10
Vascular Dissection 9 9
Vomiting 9 9
Nausea 9 9
Hypoxia 9 9
Gastrointestinal Hemorrhage 9 9
Unspecified Heart Problem 8 8
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Asystole 8 8
Syncope/Fainting 8 8
Inflammation 8 8
Mitral Insufficiency 8 8
Dysphasia 8 8
Weakness 7 7
Tissue Damage 7 7
Ventricular Tachycardia 7 7
Failure of Implant 7 7
Bacterial Infection 7 7
Anemia 6 6
Pneumothorax 6 8
Cardiogenic Shock 6 6
Confusion/ Disorientation 6 6
Cognitive Changes 5 5
No Patient Involvement 5 5
Loss of consciousness 5 5
Blurred Vision 5 5
Ischemia 5 5
Hemothorax 5 5
Hemoptysis 5 5
Convulsion/Seizure 5 5
Aortic Valve Insufficiency/ Regurgitation 4 4
Fall 4 4
Pulmonary Edema 4 4
Septic Shock 4 4

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