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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 (atrial)
Definition For the treatment of defects in the atrial septum and closure of atrial septal defects via transcatheter technique.
Product CodeOZG
Device Class 3

Premarket Approvals (PMA)
2021 2022 2023 2024 2025 2026
0 0 1 1 3 2

MDR Year MDR Reports MDR Events
2024 21 21
2025 42 42
2026 31 31

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 35 35
Difficult to Fold, Unfold or Collapse 34 34
Adverse Event Without Identified Device or Use Problem 18 18
Migration 17 17
Inadequacy of Device Shape and/or Size 16 16
Device Dislodged or Dislocated 13 13
Premature Separation 8 8
Improper or Incorrect Procedure or Method 2 2
Mechanical Jam 2 2
Difficult or Delayed Positioning 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Air/Gas in Device 1 1
Activation Problem 1 1
Insufficient Device Problem Information 1 1
Material Discolored 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Premature Activation 1 1
Physical Resistance/Sticking 1 1
Device Slipped 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 41 41
Foreign Body Embolism 24 24
Erosion 5 5
Heart Block 5 5
Insufficient Information 5 5
Thrombosis/Thrombus 4 4
Cardiac Tamponade 4 4
Arrhythmia 3 3
Low Blood Pressure/ Hypotension 3 3
Chest Pain 3 3
Laceration(s) 2 2
Cardiac Arrest 2 2
Pulmonary Embolism 2 2
Pericardial Effusion 2 2
Thromboembolism 1 1
Bradycardia 1 1
Rupture 1 1
Myocardial Contusion 1 1
Diaphoresis 1 1
Visual Impairment 1 1
Atrial Fibrillation 1 1
Non specific EKG/ECG Changes 1 1
Respiratory Tract Infection 1 1
Shock 1 1
Fistula 1 1
Cardiac Perforation 1 1
Dyspnea 1 1
Cough 1 1
Great Vessel Perforation 1 1
Ruptured Aneurysm 1 1
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 1 1
Loss of consciousness 1 1

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