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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)
2018 2019 2020 2021 2022 2023
14 27 21 14 11 3

MDR Year MDR Reports MDR Events
2018 212 212
2019 406 406
2020 407 407
2021 487 487
2022 504 504
2023 609 609

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 784 784
Difficult to Fold, Unfold or Collapse 632 632
Adverse Event Without Identified Device or Use Problem 395 395
Migration or Expulsion of Device 220 220
Biocompatibility 95 95
Patient Device Interaction Problem 94 94
Patient-Device Incompatibility 83 83
Migration 79 79
Off-Label Use 72 72
Unintended Movement 71 71
Improper or Incorrect Procedure or Method 58 58
Human-Device Interface Problem 40 40
Device Dislodged or Dislocated 33 33
Insufficient Information 30 30
Inadequacy of Device Shape and/or Size 30 30
Difficult or Delayed Positioning 16 16
Break 15 15
Material Protrusion/Extrusion 15 15
Activation Failure 12 12
Positioning Problem 11 11
Retraction Problem 11 11
Difficult to Remove 10 10
Fracture 10 10
Use of Device Problem 10 10
Detachment of Device or Device Component 9 9
Material Erosion 9 9
Leak/Splash 9 9
Material Separation 8 8
Malposition of Device 8 8
Obstruction of Flow 6 6
No Apparent Adverse Event 6 6
Entrapment of Device 6 6
Device Slipped 5 5
Mechanical Problem 5 5
Device Difficult to Setup or Prepare 5 5
Activation, Positioning or Separation Problem 5 5
Expulsion 5 5
Difficult to Advance 5 5
Premature Separation 5 5
Failure to Disconnect 4 4
Perivalvular Leak 4 4
Difficult to Insert 3 3
Loose or Intermittent Connection 3 3
Product Quality Problem 3 3
Structural Problem 3 3
Defective Component 3 3
Deformation Due to Compressive Stress 3 3
Appropriate Term/Code Not Available 3 3
Material Integrity Problem 3 3
Separation Problem 3 3
Physical Resistance/Sticking 3 3
Missing Information 2 2
Poor Visibility 2 2
Contamination /Decontamination Problem 2 2
Device Damaged by Another Device 2 2
Difficult to Open or Close 2 2
Separation Failure 2 2
Defective Device 2 2
Stretched 2 2
Material Perforation 2 2
Positioning Failure 2 2
Disconnection 1 1
Collapse 1 1
Backflow 1 1
Fluid/Blood Leak 1 1
Inadequate Instructions for Healthcare Professional 1 1
Material Invagination 1 1
Material Fragmentation 1 1
Difficult To Position 1 1
Premature Activation 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Device Appears to Trigger Rejection 1 1
Material Puncture/Hole 1 1
Failure to Advance 1 1
Compatibility Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Device Handling Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 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 1084 1084
No Known Impact Or Consequence To Patient 361 361
No Consequences Or Impact To Patient 290 290
Pericardial Effusion 140 140
Atrial Fibrillation 120 120
Thrombosis/Thrombus 78 78
Arrhythmia 63 63
Erosion 57 57
Cardiac Tamponade 53 53
Chest Pain 50 50
Stroke/CVA 49 49
Thrombus 47 47
Foreign Body Embolism 36 36
Low Blood Pressure/ Hypotension 35 35
Embolism 34 34
Tachycardia 34 34
Hemorrhage/Bleeding 32 32
Insufficient Information 29 29
Fever 27 27
Endocarditis 27 27
Cardiac Perforation 26 26
Dyspnea 25 25
No Code Available 24 24
Death 23 23
Transient Ischemic Attack 21 21
Heart Block 21 21
No Information 20 20
Atrial Flutter 20 20
Cardiac Arrest 19 19
Obstruction/Occlusion 19 19
Embolism/Embolus 19 19
Complete Heart Block 15 15
Myocardial Infarction 14 14
Hemolysis 12 12
Hypersensitivity/Allergic reaction 11 11
Pain 11 11
Headache 10 10
Bradycardia 10 10
Air Embolism 10 10
Heart Failure/Congestive Heart Failure 10 10
Failure of Implant 9 9
Loss of consciousness 9 9
Renal Failure 8 8
Angina 8 8
Mitral Valve Insufficiency/ Regurgitation 8 8
Mitral Regurgitation 7 7
Hemolytic Anemia 7 7
Nausea 6 6
Ischemia 6 6
Intracranial Hemorrhage 6 6
Hematoma 6 6
Pulmonary Embolism 6 6
Fatigue 6 6
Bacterial Infection 5 5
Palpitations 5 5
Device Embedded In Tissue or Plaque 5 5
Rash 5 5
Ventricular Fibrillation 5 5
Vomiting 5 5
Tricuspid Valve Insufficiency/ Regurgitation 5 5
Unspecified Heart Problem 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Heart Failure 4 4
Tissue Damage 4 4
Thrombosis 4 4
Dizziness 4 4
Non specific EKG/ECG Changes 4 4
Fistula 4 4
Perforation 4 4
Pleural Effusion 4 4
Hypoxia 3 3
Hearing Impairment 3 3
Unspecified Infection 3 3
Numbness 3 3
Vascular Dissection 3 3
Pseudoaneurysm 3 3
Sepsis 3 3
Rupture 3 3
Ventricular Tachycardia 3 3
Ischemia Stroke 3 3
Speech Disorder 2 2
Convulsion/Seizure 2 2
Pulmonary Hypertension 2 2
Asystole 2 2
Perforation of Vessels 2 2
Tricuspid Regurgitation 2 2
Regurgitation 2 2
Cardiogenic Shock 2 2
Septic Shock 2 2
Paresis 2 2
ST Segment Elevation 2 2
Thromboembolism 2 2
Foreign Body In Patient 2 2
Chest Tightness/Pressure 2 2
Discomfort 2 2
Chills 2 2
Reaction 2 2
Inflammation 2 2
High Blood Pressure/ Hypertension 2 2
Itching Sensation 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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