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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)
2020 2021 2022 2023 2024 2025
5 10 9 10 11 10

MDR Year MDR Reports MDR Events
2020 935 935
2021 1175 1175
2022 1493 1497
2023 2429 3398
2024 2698 15703
2025 2623 8882

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7690 23983
Difficult to Open or Close 690 2029
Migration 568 694
Device Dislodged or Dislocated 518 618
Migration or Expulsion of Device 434 470
Patient Device Interaction Problem 342 2286
Patient-Device Incompatibility 324 324
Material Deformation 314 314
Material Integrity Problem 234 236
Failure to Seal 162 162
Difficult to Remove 155 155
Detachment of Device or Device Component 135 135
Improper or Incorrect Procedure or Method 107 107
Use of Device Problem 57 57
Difficult to Fold, Unfold or Collapse 45 45
Insufficient Information 43 171
Air/Gas in Device 35 37
Premature Separation 34 34
Leak/Splash 33 33
Gas/Air Leak 30 30
No Apparent Adverse Event 25 295
Activation Failure 21 21
Difficult to Flush 20 20
Difficult to Advance 19 19
Contamination /Decontamination Problem 15 15
Device-Device Incompatibility 13 13
Biocompatibility 11 11
Malposition of Device 11 11
Material Protrusion/Extrusion 11 11
Positioning Problem 10 10
Device Contamination with Chemical or Other Material 9 9
Separation Problem 9 11
Fracture 9 9
Defective Device 8 8
Difficult or Delayed Positioning 7 7
Separation Failure 6 6
Therapeutic or Diagnostic Output Failure 5 5
Difficult to Insert 5 5
Device Difficult to Setup or Prepare 5 5
Physical Resistance/Sticking 5 5
Fluid/Blood Leak 4 4
Positioning Failure 4 4
Inadequacy of Device Shape and/or Size 4 4
Device Damaged by Another Device 3 3
Off-Label Use 3 3
Activation, Positioning or Separation Problem 2 2
Display or Visual Feedback Problem 2 2
Nonstandard Device 2 2
Break 2 2
Entrapment of Device 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3012 8134
Pericardial Effusion 2563 5747
Thrombosis/Thrombus 2237 4489
Stroke/CVA 1139 4558
Cardiac Tamponade 969 1486
Low Blood Pressure/ Hypotension 673 1188
Cardiac Perforation 520 520
Hemorrhage/Bleeding 357 1407
Transient Ischemic Attack 342 1594
Cardiac Arrest 336 558
Insufficient Information 241 2061
Thrombosis 235 235
Dyspnea 213 213
Air Embolism 173 202
No Consequences Or Impact To Patient 161 161
Chest Pain 161 162
Hematoma 155 968
Angina 148 148
Non specific EKG/ECG Changes 132 132
Pericarditis 125 220
Heart Failure/Congestive Heart Failure 116 266
Myocardial Infarction 106 242
Perforation 98 98
Thromboembolism 95 281
Perforation of Vessels 93 223
Pseudoaneurysm 88 241
Tachycardia 81 81
Bradycardia 75 75
Death 75 75
Atrial Fibrillation 71 71
Arrhythmia 71 71
Obstruction/Occlusion 69 69
Endocarditis 62 115
Embolism/Embolus 61 588
Muscle Weakness 61 61
Unspecified Infection 59 118
Pain 59 59
Unspecified Tissue Injury 53 53
Intracranial Hemorrhage 47 174
Retroperitoneal Hemorrhage 46 85
Pleural Effusion 46 59
Fistula 45 62
Pulmonary Embolism 43 60
Speech Disorder 41 41
High Blood Pressure/ Hypertension 40 40
No Code Available 38 38
Fatigue 36 36
Hypoxia 34 34
Respiratory Insufficiency 32 55
Renal Failure 31 35

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