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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
11 6 13 9 5 7 5 17 13 14 27 21 14 11 3 2

MDR Year MDR Reports MDR Events
2014 103 103
2015 133 133
2016 123 123
2017 140 140
2018 212 212
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
Material Deformation 802 802
Difficult to Fold, Unfold or Collapse 768 768
Adverse Event Without Identified Device or Use Problem 515 515
Migration or Expulsion of Device 336 336
Unintended Movement 161 161
Patient Device Interaction Problem 133 133
Biocompatibility 95 95
Patient-Device Incompatibility 91 91
Migration 87 87
Off-Label Use 80 80
Insufficient Information 76 76
Improper or Incorrect Procedure or Method 62 62
Device Dislodged or Dislocated 56 56
Inadequacy of Device Shape and/or Size 50 50
Human-Device Interface Problem 41 41
Device Operates Differently Than Expected 38 38
Positioning Problem 32 32
Break 25 25
Difficult to Remove 24 24
Difficult or Delayed Positioning 22 22
Leak/Splash 22 22
Retraction Problem 18 18
Malposition of Device 18 18
Material Protrusion/Extrusion 18 18
Fracture 17 17
Detachment of Device or Device Component 14 14
Activation Failure 13 13
Entrapment of Device 13 13
Material Erosion 13 13
Use of Device Problem 13 13
Device Slipped 11 11
Obstruction of Flow 11 11
Appropriate Term/Code Not Available 10 10
Activation, Positioning or Separation Problem 9 9
Detachment Of Device Component 9 9
Material Separation 8 8
No Apparent Adverse Event 8 8
Premature Separation 7 7
Air/Gas in Device 7 7
Occlusion Within Device 7 7
Device Difficult to Setup or Prepare 6 6
Difficult to Insert 6 6
Extrusion 6 6
Expulsion 5 5
Separation Problem 5 5
Perivalvular Leak 5 5
Mechanical Problem 5 5
Premature Activation 5 5
Difficult to Advance 5 5
Defective Device 5 5
Structural Problem 4 4
Failure to Disconnect 4 4
Defective Component 4 4
Difficult To Position 4 4
Material Fragmentation 4 4
Loose or Intermittent Connection 4 4
Positioning Failure 4 4
Stretched 3 3
Product Quality Problem 3 3
Failure to Advance 3 3
Difficult to Open or Close 3 3
Deformation Due to Compressive Stress 3 3
Physical Resistance/Sticking 3 3
Material Integrity Problem 3 3
Device Handling Problem 2 2
Material Twisted/Bent 2 2
Missing Information 2 2
Poor Visibility 2 2
Contamination /Decontamination Problem 2 2
Device Damaged by Another Device 2 2
Separation Failure 2 2
Sticking 2 2
Material Too Rigid or Stiff 2 2
Unstable 2 2
Microbial Contamination of Device 2 2
Material Perforation 2 2
Material Rupture 1 1
Device Appears to Trigger Rejection 1 1
Failure to Align 1 1
Folded 1 1
Disconnection 1 1
Fluid/Blood Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Invagination 1 1
Kinked 1 1
Component Falling 1 1
Backflow 1 1
Partial Blockage 1 1
Failure to Capture 1 1
Complete Blockage 1 1
Collapse 1 1
Unintended Collision 1 1
Pacing Problem 1 1
Misconnection 1 1
Nonstandard Device 1 1
Decrease in Pressure 1 1
Material Puncture/Hole 1 1
Difficult or Delayed Separation 1 1
Activation Problem 1 1
Material Split, Cut or Torn 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 390 390
No Consequences Or Impact To Patient 360 360
Pericardial Effusion 188 188
Atrial Fibrillation 139 139
Embolism 105 105
Thrombosis/Thrombus 98 98
Erosion 88 88
No Code Available 87 87
Cardiac Tamponade 81 81
Arrhythmia 78 78
Chest Pain 65 65
Thrombus 65 65
Stroke/CVA 63 63
Low Blood Pressure/ Hypotension 48 48
Hemorrhage/Bleeding 47 47
Foreign Body Embolism 43 43
Tachycardia 42 42
Cardiac Perforation 41 41
Endocarditis 39 39
Death 39 39
Dyspnea 38 38
No Information 38 38
Insufficient Information 37 37
Fever 35 35
Obstruction/Occlusion 35 35
Heart Block 29 29
Complete Heart Block 29 29
Transient Ischemic Attack 28 28
Cardiac Arrest 26 26
Atrial Flutter 22 22
Headache 22 22
Hemolysis 21 21
Embolism/Embolus 21 21
Bradycardia 19 19
Congenital Defect/Deformity 18 18
Myocardial Infarction 17 17
Pain 17 17
Air Embolism 16 16
Heart Failure/Congestive Heart Failure 16 16
Hypersensitivity/Allergic reaction 15 15
Perforation 14 14
Ventricular Tachycardia 13 13
Renal Failure 12 12
Regurgitation 12 12
Ventricular Fibrillation 11 11
Device Embedded In Tissue or Plaque 11 11
Loss of consciousness 10 10
Fatigue 10 10
Nausea 10 10
Failure of Implant 10 10
Angina 10 10
Pulmonary Embolism 9 9
Mitral Regurgitation 9 9
Vomiting 9 9
Thrombosis 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Tricuspid Valve Insufficiency/ Regurgitation 9 9
Foreign Body In Patient 8 8
Tissue Damage 8 8
Rupture 8 8
Fistula 8 8
Hematoma 8 8
Ischemia 7 7
Therapeutic Response, Decreased 7 7
Hemolytic Anemia 7 7
Complaint, Ill-Defined 7 7
Palpitations 7 7
Rash 7 7
Pleural Effusion 7 7
Heart Failure 6 6
Intracranial Hemorrhage 6 6
Bacterial Infection 5 5
Unspecified Infection 5 5
Syncope 5 5
Non specific EKG/ECG Changes 5 5
Dizziness 5 5
Cardiogenic Shock 5 5
Discomfort 5 5
Pulmonary Edema 5 5
Staphylococcus Aureus 5 5
Sepsis 5 5
Tricuspid Regurgitation 5 5
Pseudoaneurysm 5 5
Unspecified Heart Problem 5 5
Unspecified Tissue Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Thromboembolism 4 4
Vascular Dissection 4 4
Shock 4 4
Respiratory Distress 4 4
Injury 4 4
Embolus 4 4
Hypoxia 4 4
High Blood Pressure/ Hypertension 4 4
Hearing Impairment 3 3
Occlusion 3 3
Congestive Heart Failure 3 3
Anemia 3 3
Aneurysm 3 3

Recalls
Manufacturer Recall Class Date Posted
1 EXP Pharmaceutical Services Corp II Jul-24-2015
2 W L Gore & Associates, Inc. II Feb-01-2023
3 W L Gore & Associates, Inc. II Oct-26-2022
4 W L Gore & Associates, Inc. II Oct-22-2021
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