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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)
2021 2022 2023 2024 2025 2026
10 9 10 11 15 8

MDR Year MDR Reports MDR Events
2021 1175 1175
2022 1493 1497
2023 2429 3398
2024 2698 15703
2025 2850 10642
2026 1279 5308

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 7990 28435
Difficult to Open or Close 666 2356
Migration 652 813
Device Dislodged or Dislocated 516 619
Migration or Expulsion of Device 483 520
Patient Device Interaction Problem 396 3361
Patient-Device Incompatibility 379 379
Failure to Seal 350 669
Material Deformation 311 311
Material Integrity Problem 219 221
Difficult to Remove 135 135
Detachment of Device or Device Component 121 121
Improper or Incorrect Procedure or Method 115 115
Use of Device Problem 71 71
Premature Separation 60 60
Difficult to Fold, Unfold or Collapse 48 48
Insufficient Information 45 173
Air/Gas in Device 39 41
Activation Failure 28 28
No Apparent Adverse Event 24 294
Gas/Air Leak 22 22
Nonstandard Device 21 21
Difficult to Flush 21 21
Leak/Splash 20 20
Difficult to Advance 20 20
Contamination /Decontamination Problem 17 17
Material Protrusion/Extrusion 15 15
Device-Device Incompatibility 14 14
Fracture 14 14
Positioning Problem 12 12
Biocompatibility 11 11
Difficult or Delayed Positioning 11 11
Separation Problem 10 12
Malposition of Device 10 10
Device Contamination with Chemical or Other Material 9 9
Therapeutic or Diagnostic Output Failure 8 8
Defective Device 8 8
Off-Label Use 8 8
Deformation Due to Compressive Stress 8 8
Physical Resistance/Sticking 7 7
Device Difficult to Setup or Prepare 6 6
Output Problem 6 6
Difficult to Insert 5 5
Difficult or Delayed Separation 5 5
Inadequacy of Device Shape and/or Size 5 5
Separation Failure 5 5
Material Twisted/Bent 4 4
Positioning Failure 4 4
Device Damaged by Another Device 3 3
Fluid/Blood Leak 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3437 9851
Pericardial Effusion 2598 6397
Thrombosis/Thrombus 2502 5215
Stroke/CVA 1202 5827
Cardiac Tamponade 1078 1690
Low Blood Pressure/ Hypotension 721 2252
Cardiac Perforation 501 501
Hemorrhage/Bleeding 413 2153
Transient Ischemic Attack 382 1879
Cardiac Arrest 370 636
Insufficient Information 254 2110
Dyspnea 248 248
Chest Pain 192 193
Air Embolism 175 208
Angina 173 173
Hematoma 171 1131
Pericarditis 158 260
Non specific EKG/ECG Changes 155 155
Heart Failure/Congestive Heart Failure 146 354
Myocardial Infarction 124 294
Thromboembolism 118 336
Perforation of Vessels 106 259
Tachycardia 102 102
Perforation 99 99
Pseudoaneurysm 95 286
Bradycardia 93 93
Arrhythmia 87 87
Muscle Weakness 82 82
Endocarditis 79 138
Atrial Fibrillation 79 79
Embolism/Embolus 77 1197
Obstruction/Occlusion 73 73
Pain 68 68
Intracranial Hemorrhage 66 219
Unspecified Tissue Injury 66 68
Unspecified Infection 64 128
Speech Disorder 54 54
Retroperitoneal Hemorrhage 51 103
Pleural Effusion 49 62
High Blood Pressure/ Hypertension 47 47
Fistula 47 73
Pulmonary Embolism 45 62
Fatigue 40 40
Hypoxia 39 39
Numbness 38 38
Renal Failure 38 49
Dizziness 38 38
Syncope/Fainting 35 35
Mitral Valve Insufficiency/ Regurgitation 34 34
Respiratory Insufficiency 33 56

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