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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device transcatheter septal occluder
Definition Approved PMA: P000039
Product CodeMLV
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
27 21 14 11 3 3

MDR Year MDR Reports MDR Events
2019 406 406
2020 407 407
2021 487 487
2022 504 504
2023 673 673
2024 203 203

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Fold, Unfold or Collapse 768 768
Material Deformation 699 699
Adverse Event Without Identified Device or Use Problem 410 410
Migration or Expulsion of Device 234 234
Patient Device Interaction Problem 128 128
Biocompatibility 93 93
Migration 87 87
Patient-Device Incompatibility 84 84
Off-Label Use 78 78
Improper or Incorrect Procedure or Method 62 62
Human-Device Interface Problem 40 40
Unintended Movement 34 34
Device Dislodged or Dislocated 34 34
Inadequacy of Device Shape and/or Size 27 27
Insufficient Information 16 16
Material Protrusion/Extrusion 16 16
Break 15 15
Difficult or Delayed Positioning 15 15
Activation Failure 13 13
Fracture 12 12
Detachment of Device or Device Component 11 11
Malposition of Device 10 10
Use of Device Problem 10 10
Difficult to Remove 10 10
Retraction Problem 9 9
Leak/Splash 9 9
Material Separation 8 8
Positioning Problem 8 8
No Apparent Adverse Event 8 8
Premature Separation 7 7
Air/Gas in Device 7 7
Device Difficult to Setup or Prepare 6 6
Entrapment of Device 6 6
Material Erosion 5 5
Obstruction of Flow 5 5
Activation, Positioning or Separation Problem 5 5
Expulsion 5 5
Separation Problem 5 5
Difficult to Advance 4 4
Mechanical Problem 4 4
Device Slipped 4 4
Defective Component 3 3
Product Quality Problem 3 3
Perivalvular Leak 3 3
Loose or Intermittent Connection 3 3
Structural Problem 3 3
Failure to Disconnect 3 3
Deformation Due to Compressive Stress 3 3
Material Integrity Problem 3 3
Device Handling Problem 2 2
Contamination /Decontamination Problem 2 2
Defective Device 2 2
Difficult to Open or Close 2 2
Device Damaged by Another Device 2 2
Difficult to Insert 2 2
Positioning Failure 2 2
Material Perforation 2 2
Stretched 2 2
Physical Resistance/Sticking 2 2
Poor Visibility 2 2
Missing Information 2 2
Activation Problem 1 1
Difficult or Delayed Separation 1 1
Device Appears to Trigger Rejection 1 1
Material Puncture/Hole 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Disconnection 1 1
Collapse 1 1
Fluid/Blood Leak 1 1
Material Fragmentation 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Invagination 1 1
Backflow 1 1
Separation Failure 1 1
Failure to Advance 1 1
Material Split, Cut or Torn 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Compatibility Problem 1 1
Material Twisted/Bent 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1259 1259
No Known Impact Or Consequence To Patient 298 298
No Consequences Or Impact To Patient 216 216
Pericardial Effusion 131 131
Atrial Fibrillation 130 130
Thrombosis/Thrombus 98 98
Arrhythmia 65 65
Stroke/CVA 58 58
Erosion 52 52
Cardiac Tamponade 49 49
Foreign Body Embolism 43 43
Thrombus 42 42
Chest Pain 41 41
Hemorrhage/Bleeding 39 39
Tachycardia 37 37
Insufficient Information 37 37
Low Blood Pressure/ Hypotension 36 36
Fever 33 33
Embolism 32 32
Endocarditis 30 30
Heart Block 29 29
Obstruction/Occlusion 28 28
Dyspnea 27 27
Transient Ischemic Attack 23 23
No Code Available 22 22
Atrial Flutter 21 21
Embolism/Embolus 21 21
Cardiac Arrest 18 18
Headache 16 16
Bradycardia 16 16
Cardiac Perforation 16 16
Heart Failure/Congestive Heart Failure 16 16
Hemolysis 15 15
Hypersensitivity/Allergic reaction 14 14
Myocardial Infarction 14 14
Complete Heart Block 14 14
Death 13 13
Air Embolism 12 12
Pain 12 12
Perforation 12 12
No Information 12 12
Ventricular Fibrillation 10 10
Renal Failure 10 10
Angina 10 10
Loss of consciousness 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Tricuspid Valve Insufficiency/ Regurgitation 9 9
Fatigue 8 8
Nausea 8 8
Hematoma 8 8
Failure of Implant 8 8
Ischemia 7 7
Rash 7 7
Vomiting 7 7
Hemolytic Anemia 6 6
Intracranial Hemorrhage 6 6
Pulmonary Embolism 6 6
Non specific EKG/ECG Changes 5 5
Foreign Body In Patient 5 5
Unspecified Heart Problem 5 5
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Pseudoaneurysm 4 4
Heart Failure 4 4
Thrombosis 4 4
Fistula 4 4
Bacterial Infection 4 4
Hypoxia 4 4
Pleural Effusion 4 4
Hemothorax 3 3
Mitral Regurgitation 3 3
Unspecified Infection 3 3
Hearing Impairment 3 3
Sepsis 3 3
Ventricular Tachycardia 3 3
Palpitations 3 3
Numbness 3 3
Vascular Dissection 3 3
Pulmonary Hypertension 3 3
Ischemia Stroke 3 3
Asystole 2 2
Device Embedded In Tissue or Plaque 2 2
Thromboembolism 2 2
Convulsion/Seizure 2 2
Syncope/Fainting 2 2
Movement Disorder 2 2
Speech Disorder 2 2
Reaction 2 2
Discomfort 2 2
Chest Tightness/Pressure 2 2
Cognitive Changes 2 2
Perforation of Vessels 2 2
Septic Shock 2 2
Paresis 2 2
Rupture 2 2
Tissue Damage 2 2
Chills 2 2
Dizziness 2 2
Regurgitation 2 2
Cardiogenic Shock 2 2

Recalls
Manufacturer Recall Class Date Posted
1 W L Gore & Associates, Inc. II Feb-01-2023
2 W L Gore & Associates, Inc. II Oct-26-2022
3 W L Gore & Associates, Inc. II Oct-22-2021
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