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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device occluder, patent ductus, arteriosus
Product CodeMAE
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
9 7 7 6 5 3 2 10 3 1 6 6 1 1 1 1

MDR Year MDR Reports MDR Events
2014 28 28
2015 24 24
2016 12 12
2017 23 23
2018 28 28
2019 53 53
2020 109 109
2021 76 76
2022 80 80
2023 128 128
2024 79 79

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 225 225
Difficult to Fold, Unfold or Collapse 87 87
Adverse Event Without Identified Device or Use Problem 68 68
Improper or Incorrect Procedure or Method 54 54
Material Deformation 48 48
Unintended Movement 42 42
Off-Label Use 39 39
Patient Device Interaction Problem 38 38
Migration 20 20
Malposition of Device 19 19
Obstruction of Flow 19 19
Inadequacy of Device Shape and/or Size 16 16
Patient-Device Incompatibility 14 14
Use of Device Problem 12 12
Human-Device Interface Problem 11 11
Biocompatibility 9 9
Activation, Positioning or Separation Problem 8 8
Device Dislodged or Dislocated 8 8
Retraction Problem 7 7
Leak/Splash 6 6
Gradient Increase 6 6
Insufficient Information 6 6
Device Operates Differently Than Expected 6 6
Failure to Advance 6 6
Difficult to Insert 6 6
Premature Activation 5 5
Premature Separation 5 5
Difficult to Remove 5 5
Positioning Problem 5 5
Appropriate Term/Code Not Available 4 4
Material Protrusion/Extrusion 3 3
No Apparent Adverse Event 3 3
Detachment of Device or Device Component 3 3
Material Separation 3 3
Device Slipped 3 3
Occlusion Within Device 2 2
Difficult or Delayed Positioning 2 2
Difficult to Advance 2 2
Material Erosion 2 2
Entrapment of Device 2 2
Break 2 2
Unintended Ejection 1 1
Device Difficult to Setup or Prepare 1 1
Fracture 1 1
Inaccurate Flow Rate 1 1
Material Integrity Problem 1 1
Activation Failure 1 1
Mechanical Jam 1 1
Connection Problem 1 1
Inaccurate Information 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 213 213
Obstruction/Occlusion 74 74
No Known Impact Or Consequence To Patient 64 64
Embolism 61 61
No Consequences Or Impact To Patient 57 57
Insufficient Information 22 22
Foreign Body Embolism 18 18
Hemorrhage/Bleeding 17 17
Arrhythmia 14 14
High Blood Pressure/ Hypertension 12 12
Thrombosis/Thrombus 12 12
Pericardial Effusion 12 12
No Code Available 12 12
Tricuspid Valve Insufficiency/ Regurgitation 12 12
Low Blood Pressure/ Hypotension 11 11
Death 11 11
Foreign Body In Patient 10 10
Cardiac Tamponade 10 10
Hemolysis 10 10
Sepsis 10 10
Hypoxia 10 10
Renal Failure 10 10
Heart Failure/Congestive Heart Failure 9 9
Dyspnea 8 8
Stenosis 8 8
Tachycardia 8 8
Respiratory Insufficiency 6 6
Heart Block 6 6
Complete Heart Block 6 6
No Information 6 6
Cardiac Perforation 5 5
Tissue Damage 5 5
Bradycardia 5 5
Hematoma 5 5
Perforation 5 5
Chest Pain 4 4
Cardiac Arrest 4 4
Rash 3 3
Regurgitation 3 3
Embolism/Embolus 3 3
Inflammation 3 3
Myocardial Infarction 3 3
Memory Loss/Impairment 3 3
Failure of Implant 3 3
Headache 3 3
Aortic Valve Insufficiency/ Regurgitation 3 3
Aortic Valve Stenosis 3 3
Pulmonary Embolism 3 3
Fistula 3 3
Patient Problem/Medical Problem 3 3

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