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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)
2017 2018 2019 2020 2021 2022
13 14 27 21 14 6

MDR Year MDR Reports MDR Events
2017 140 140
2018 212 212
2019 406 406
2020 407 407
2021 487 487
2022 162 162

Device Problems MDRs with this Device Problem Events in those MDRs
Material Deformation 793 793
Adverse Event Without Identified Device or Use Problem 302 302
Migration or Expulsion of Device 137 137
Unintended Movement 107 107
Biocompatibility 91 91
Patient-Device Incompatibility 58 58
Migration 52 52
Difficult to Fold, Unfold or Collapse 52 52
Human-Device Interface Problem 41 41
Off-Label Use 39 39
Insufficient Information 38 38
Patient Device Interaction Problem 33 33
Inadequacy of Device Shape and/or Size 29 29
Improper or Incorrect Procedure or Method 25 25
Device Dislodged or Dislocated 23 23
Leak/Splash 16 16
Retraction Problem 14 14
Break 13 13
Material Erosion 11 11
Positioning Problem 11 11
Device Operates Differently Than Expected 10 10
Use of Device Problem 9 9
Difficult or Delayed Positioning 8 8
Fracture 8 8
Detachment of Device or Device Component 8 8
Activation Failure 8 8
Material Protrusion/Extrusion 7 7
Difficult to Remove 7 7
Device Slipped 6 6
Obstruction of Flow 6 6
Material Separation 5 5
Entrapment of Device 5 5
No Apparent Adverse Event 5 5
Expulsion 5 5
Activation, Positioning or SeparationProblem 4 4
Failure to Disconnect 4 4
Appropriate Term/Code Not Available 4 4
Perivalvular Leak 4 4
Mechanical Problem 4 4
Loose or Intermittent Connection 3 3
Difficult to Insert 3 3
Physical Resistance/Sticking 3 3
Malposition of Device 3 3
Material Integrity Problem 3 3
Difficult to Advance 2 2
Deformation Due to Compressive Stress 2 2
Missing Information 2 2
Difficult To Position 2 2
Positioning Failure 2 2
Detachment Of Device Component 2 2
Structural Problem 2 2
Material Perforation 2 2
Defective Component 2 2
Stretched 1 1
Product Quality Problem 1 1
Device Appears to Trigger Rejection 1 1
Material Too Rigid or Stiff 1 1
Material Rupture 1 1
Backflow 1 1
Complete Blockage 1 1
Collapse 1 1
Disconnection 1 1
Fluid Leak 1 1
Premature Activation 1 1
Material Fragmentation 1 1
Difficult or Delayed Separation 1 1
Material Split, Cut or Torn 1 1
Device Handling Problem 1 1
Material Twisted/Bent 1 1
Mechanical Jam 1 1
Contamination /Decontamination Problem 1 1
Separation Failure 1 1
Difficult to Open or Close 1 1
Compatibility Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 392 392
No Known Impact Or Consequence To Patient 364 364
No Consequences Or Impact To Patient 321 321
Pericardial Effusion 126 126
Atrial Fibrillation 71 71
Erosion 67 67
Cardiac Tamponade 56 56
Arrhythmia 54 54
Chest Pain 52 52
Thrombus 52 52
Thrombosis/Thrombus 39 39
Embolism 37 37
No Code Available 36 36
Stroke/CVA 30 30
Death 29 29
Cardiac Perforation 29 29
Hemorrhage/Bleeding 27 27
Low Blood Pressure/ Hypotension 24 24
No Information 23 23
Tachycardia 22 22
Dyspnea 21 21
Endocarditis 21 21
Fever 20 20
Complete Heart Block 19 19
Obstruction/Occlusion 16 16
Cardiac Arrest 15 15
Insufficient Information 15 15
Embolism/Embolus 14 14
Atrial Flutter 13 13
Hemolysis 12 12
Transient Ischemic Attack 12 12
Foreign Body Embolism 11 11
Headache 10 10
Air Embolism 10 10
Failure of Implant 10 10
Loss of consciousness 9 9
Heart Block 9 9
Regurgitation 8 8
Pain 8 8
Fistula 8 8
Nausea 7 7
Mitral Regurgitation 7 7
Thrombosis 7 7
Ventricular Tachycardia 7 7
Tissue Damage 6 6
Heart Failure 6 6
Device Embedded In Tissue or Plaque 6 6
Palpitations 6 6
Ischemia 6 6
Hypersensitivity/Allergic reaction 6 6
Myocardial Infarction 6 6
Pulmonary Embolism 6 6
Bradycardia 6 6
Mitral Valve Insufficiency/ Regurgitation 6 6
Bacterial Infection 5 5
Perforation 5 5
Rash 5 5
Renal Failure 5 5
Intracranial Hemorrhage 5 5
Vomiting 5 5
Rupture 4 4
Dizziness 4 4
Pseudoaneurysm 4 4
Pleural Effusion 4 4
Fatigue 4 4
Hematoma 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Heart Failure/Congestive Heart Failure 4 4
Hearing Impairment 3 3
Pulmonary Edema 3 3
Respiratory Distress 3 3
Thromboembolism 3 3
Discomfort 3 3
Numbness 3 3
Cardiogenic Shock 3 3
Tricuspid Regurgitation 3 3
Shock 3 3
Ventricular Fibrillation 2 2
Chills 2 2
Collapse 2 2
Reaction 2 2
Hemolytic Anemia 2 2
Chest Tightness/Pressure 2 2
Blood Loss 2 2
Low Oxygen Saturation 2 2
Foreign Body In Patient 2 2
Vascular Dissection 2 2
Ischemia Stroke 2 2
ST Segment Elevation 2 2
Paresis 2 2
High Blood Pressure/ Hypertension 2 2
Itching Sensation 2 2
Muscle Weakness 2 2
Embolus 2 2
Infarction, Cerebral 2 2
Autoimmune Reaction 2 2
Syncope 2 2
Anemia 2 2
Pulmonary Hypertension 2 2
Liver Failure 1 1

Recalls
Manufacturer Recall Class Date Posted
1 W L Gore & Associates, Inc. II Oct-22-2021
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