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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 6

MDR Year MDR Reports MDR Events
2019 406 406
2020 407 407
2021 487 487
2022 504 504
2023 673 673
2024 560 560

Device Problems MDRs with this Device Problem Events in those MDRs
Difficult to Fold, Unfold or Collapse 961 961
Material Deformation 699 699
Adverse Event Without Identified Device or Use Problem 471 471
Migration or Expulsion of Device 257 257
Patient Device Interaction Problem 172 172
Patient-Device Incompatibility 100 100
Migration 99 99
Off-Label Use 97 97
Biocompatibility 93 93
Improper or Incorrect Procedure or Method 69 69
Human-Device Interface Problem 40 40
Device Dislodged or Dislocated 38 38
Unintended Movement 34 34
Inadequacy of Device Shape and/or Size 27 27
Difficult or Delayed Positioning 17 17
Material Protrusion/Extrusion 17 17
Insufficient Information 16 16
Break 16 16
Activation Failure 13 13
Detachment of Device or Device Component 13 13
Fracture 12 12
Difficult to Remove 11 11
Malposition of Device 11 11
Retraction Problem 10 10
Use of Device Problem 10 10
Positioning Problem 9 9
Leak/Splash 9 9
Material Separation 8 8
No Apparent Adverse Event 8 8
Device Appears to Trigger Rejection 8 8
Premature Separation 7 7
Air/Gas in Device 7 7
Separation Problem 6 6
Device Difficult to Setup or Prepare 6 6
Entrapment of Device 6 6
Activation, Positioning or Separation Problem 5 5
Expulsion 5 5
Positioning Failure 5 5
Obstruction of Flow 5 5
Material Erosion 5 5
Device Slipped 4 4
Difficult to Advance 4 4
Mechanical Problem 4 4
Contamination /Decontamination Problem 4 4
Product Quality Problem 3 3
Perivalvular Leak 3 3
Failure to Disconnect 3 3
Deformation Due to Compressive Stress 3 3
Loose or Intermittent Connection 3 3
Structural Problem 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 1498 1498
No Known Impact Or Consequence To Patient 298 298
No Consequences Or Impact To Patient 216 216
Atrial Fibrillation 163 163
Pericardial Effusion 140 140
Thrombosis/Thrombus 122 122
Arrhythmia 75 75
Stroke/CVA 71 71
Erosion 57 57
Cardiac Tamponade 53 53
Foreign Body Embolism 50 50
Insufficient Information 46 46
Hemorrhage/Bleeding 46 46
Tachycardia 43 43
Thrombus 42 42
Chest Pain 41 41
Low Blood Pressure/ Hypotension 41 41
Heart Block 39 39
Fever 35 35
Endocarditis 34 34
Embolism 32 32
Obstruction/Occlusion 31 31
Dyspnea 31 31
Transient Ischemic Attack 27 27
Atrial Flutter 26 26
Embolism/Embolus 23 23
No Code Available 22 22
Cardiac Arrest 20 20
Bradycardia 18 18
Cardiac Perforation 17 17
Heart Failure/Congestive Heart Failure 17 17
Headache 16 16
Hemolysis 16 16
Myocardial Infarction 15 15
Perforation 14 14
Air Embolism 14 14
Hypersensitivity/Allergic reaction 14 14
Complete Heart Block 14 14
Death 13 13
Angina 13 13
Pain 13 13
No Information 12 12
Tricuspid Valve Insufficiency/ Regurgitation 11 11
Ventricular Fibrillation 10 10
Renal Failure 10 10
Hematoma 9 9
Loss of consciousness 9 9
Fatigue 9 9
Mitral Valve Insufficiency/ Regurgitation 9 9
Nausea 8 8

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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