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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)
2021 2022 2023 2024 2025 2026
1 1 1 4 1 0

MDR Year MDR Reports MDR Events
2021 76 76
2022 80 83
2023 127 128
2024 117 117
2025 180 180

Device Problems MDRs with this Device Problem Events in those MDRs
Migration or Expulsion of Device 201 204
Difficult to Fold, Unfold or Collapse 167 168
Adverse Event Without Identified Device or Use Problem 91 91
Patient Device Interaction Problem 70 70
Off-Label Use 47 47
Improper or Incorrect Procedure or Method 35 35
Material Deformation 19 19
Malposition of Device 15 15
Patient-Device Incompatibility 12 12
Premature Separation 9 9
Migration 8 8
Human-Device Interface Problem 8 8
Obstruction of Flow 6 6
Difficult to Advance 4 4
Use of Device Problem 4 4
No Apparent Adverse Event 4 4
Device Difficult to Setup or Prepare 3 3
Material Protrusion/Extrusion 3 3
Separation Problem 2 2
Insufficient Information 2 2
Inadequacy of Device Shape and/or Size 2 2
Device Dislodged or Dislocated 2 2
Activation, Positioning or Separation Problem 1 1
Break 1 1
Entrapment of Device 1 1
Difficult to Remove 1 1
Difficult to Insert 1 1
Inaccurate Flow Rate 1 1
Device Damaged by Another Device 1 1
Difficult or Delayed Positioning 1 1
Detachment of Device or Device Component 1 1
Activation Failure 1 1
Fracture 1 1
Inaccurate Information 1 1
Fluid/Blood Leak 1 1
Biocompatibility 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 342 343
Obstruction/Occlusion 77 77
Insufficient Information 33 36
Hemorrhage/Bleeding 21 21
Arrhythmia 20 20
Tricuspid Valve Insufficiency/ Regurgitation 20 20
Thrombosis/Thrombus 17 17
Foreign Body Embolism 16 16
Heart Block 15 15
Sepsis 15 15
Low Blood Pressure/ Hypotension 14 14
Hypoxia 14 14
Pericardial Effusion 14 14
Renal Failure 12 12
Heart Failure/Congestive Heart Failure 12 12
Unspecified Infection 11 11
Hemolysis 11 11
Tachycardia 11 11
Bradycardia 10 10
Cardiac Tamponade 10 10
High Blood Pressure/ Hypertension 9 9
Aortic Valve Insufficiency/ Regurgitation 9 9
Respiratory Insufficiency 8 8
Perforation 6 6
Embolism/Embolus 6 6
Dyspnea 6 6
Cardiac Arrest 6 6
Aortic Valve Stenosis 5 5
Hematoma 5 5
Embolism 4 4
Stenosis 4 4
Inflammation 4 4
Pulmonary Embolism 3 3
Cardiac Perforation 3 3
Pulmonary Hypertension 3 3
Anemia 3 3
Failure of Implant 3 3
Unspecified Tissue Injury 3 3
Pseudoaneurysm 3 3
Myocardial Infarction 3 3
Foreign Body In Patient 2 2
Pleural Effusion 2 2
Pulmonary Valve Stenosis 2 2
Respiratory Tract Infection 2 2
Atrial Flutter 2 2
Valvular Insufficiency/ Regurgitation 2 2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 2 2
Stroke/CVA 2 2
Pneumonia 2 2
Necrosis 2 2

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