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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 1

MDR Year MDR Reports MDR Events
2020 935 935
2021 1175 1175
2022 1493 1493
2023 2430 3397
2024 2701 15700
2025 557 2217

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 6354 19094
Difficult to Open or Close 639 1530
Migration 441 547
Device Dislodged or Dislocated 428 469
Migration or Expulsion of Device 324 358
Material Deformation 303 303
Patient Device Interaction Problem 244 1659
Patient-Device Incompatibility 237 237
Material Integrity Problem 207 208
Difficult to Remove 141 141
Detachment of Device or Device Component 114 114
Improper or Incorrect Procedure or Method 85 85
Use of Device Problem 46 46
Insufficient Information 42 170
Difficult to Fold, Unfold or Collapse 35 35
Air/Gas in Device 33 33
Leak/Splash 32 32
Gas/Air Leak 30 30
Premature Separation 25 25
No Apparent Adverse Event 24 294
Difficult to Flush 18 18
Difficult to Advance 18 18
Contamination /Decontamination Problem 14 14
Biocompatibility 11 11
Device-Device Incompatibility 10 10
Malposition of Device 10 10
Material Protrusion/Extrusion 10 10
Activation Failure 9 9
Positioning Problem 9 9
Fracture 8 8
Defective Device 8 8
Device Contamination with Chemical or Other Material 8 8
Difficult or Delayed Positioning 7 7
Device Difficult to Setup or Prepare 5 5
Fluid/Blood Leak 4 4
Positioning Failure 4 4
Difficult to Insert 4 4
Physical Resistance/Sticking 4 4
Separation Problem 4 4
Inadequacy of Device Shape and/or Size 3 3
Therapeutic or Diagnostic Output Failure 3 3
Separation Failure 3 3
Device Damaged by Another Device 2 2
Obstruction of Flow 2 2
Activation Problem 2 2
Output Problem 2 2
Off-Label Use 2 2
Break 2 2
Contamination 1 1
Device Markings/Labelling Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 2426 6081
Pericardial Effusion 2081 4282
Thrombosis/Thrombus 1806 3672
Stroke/CVA 916 3267
Cardiac Tamponade 744 1199
Low Blood Pressure/ Hypotension 529 529
Cardiac Perforation 437 437
Cardiac Arrest 270 468
Transient Ischemic Attack 270 1336
Hemorrhage/Bleeding 267 719
Thrombosis 235 235
Insufficient Information 217 2007
No Consequences Or Impact To Patient 161 161
Dyspnea 154 154
Air Embolism 137 161
Hematoma 134 857
Chest Pain 119 119
Angina 110 110
Non specific EKG/ECG Changes 100 100
Pericarditis 92 175
Perforation of Vessels 84 185
Heart Failure/Congestive Heart Failure 82 165
Myocardial Infarction 81 192
Perforation 76 76
Death 75 75
Pseudoaneurysm 74 197
Thromboembolism 67 233
Tachycardia 59 59
Bradycardia 58 58
Obstruction/Occlusion 55 55
Atrial Fibrillation 51 51
Endocarditis 48 95
Arrhythmia 47 47
Pain 44 44
Muscle Weakness 42 42
Retroperitoneal Hemorrhage 41 71
Unspecified Infection 41 86
Fistula 40 53
Pulmonary Embolism 39 56
No Code Available 38 38
Unspecified Tissue Injury 38 38
Intracranial Hemorrhage 38 145
Pleural Effusion 35 48
Embolism/Embolus 35 37
Respiratory Insufficiency 28 51
Speech Disorder 27 27
High Blood Pressure/ Hypertension 24 24
Mitral Valve Insufficiency/ Regurgitation 23 23
Fatigue 23 23
Hypoxia 22 22

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