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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)
2019 2020 2021 2022 2023 2024
6 6 1 1 1 1

MDR Year MDR Reports MDR Events
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 202 202
Difficult to Fold, Unfold or Collapse 87 87
Adverse Event Without Identified Device or Use Problem 58 58
Improper or Incorrect Procedure or Method 52 52
Off-Label Use 39 39
Patient Device Interaction Problem 38 38
Material Deformation 38 38
Migration 20 20
Obstruction of Flow 18 18
Unintended Movement 18 18
Malposition of Device 16 16
Patient-Device Incompatibility 12 12
Human-Device Interface Problem 11 11
Use of Device Problem 10 10
Biocompatibility 9 9
Inadequacy of Device Shape and/or Size 8 8
Gradient Increase 6 6
Premature Separation 5 5
Difficult to Insert 5 5
Device Dislodged or Dislocated 4 4
Failure to Advance 4 4
No Apparent Adverse Event 3 3
Activation, Positioning or Separation Problem 3 3
Positioning Problem 3 3
Detachment of Device or Device Component 2 2
Material Separation 2 2
Break 2 2
Difficult or Delayed Positioning 2 2
Difficult to Advance 2 2
Insufficient Information 2 2
Material Protrusion/Extrusion 1 1
Activation Failure 1 1
Retraction Problem 1 1
Connection Problem 1 1
Inaccurate Information 1 1
Expulsion 1 1
Leak/Splash 1 1
Inaccurate Flow Rate 1 1
Difficult to Remove 1 1
Entrapment of Device 1 1
Fracture 1 1
Device Difficult to Setup or Prepare 1 1
Unintended Ejection 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 213 213
Obstruction/Occlusion 73 73
No Known Impact Or Consequence To Patient 51 51
Embolism 42 42
No Consequences Or Impact To Patient 24 24
Insufficient Information 22 22
Foreign Body Embolism 18 18
Hemorrhage/Bleeding 16 16
Arrhythmia 13 13
Thrombosis/Thrombus 12 12
Tricuspid Valve Insufficiency/ Regurgitation 12 12
Pericardial Effusion 11 11
High Blood Pressure/ Hypertension 10 10
Renal Failure 10 10
Sepsis 10 10
Heart Failure/Congestive Heart Failure 9 9
Low Blood Pressure/ Hypotension 9 9
Cardiac Tamponade 9 9
Hypoxia 9 9
Stenosis 8 8
Hemolysis 8 8
Tachycardia 7 7
Death 7 7
Dyspnea 6 6
Respiratory Insufficiency 6 6
Heart Block 6 6
Bradycardia 5 5
Complete Heart Block 5 5
Hematoma 5 5
Perforation 5 5
Cardiac Arrest 4 4
Foreign Body In Patient 4 4
Embolism/Embolus 3 3
Inflammation 3 3
Aortic Valve Insufficiency/ Regurgitation 3 3
No Information 3 3
Myocardial Infarction 3 3
Aortic Valve Stenosis 3 3
Cardiac Perforation 3 3
Failure of Implant 3 3
Unspecified Infection 3 3
Pulmonary Embolism 3 3
Valvular Insufficiency/ Regurgitation 2 2
Necrosis 2 2
Pseudoaneurysm 2 2
Endocarditis 2 2
Hemolytic Anemia 2 2
Thrombosis 2 2
Unspecified Tissue Injury 2 2
Pulmonary Valve Stenosis 2 2

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