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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device shunt, portosystemic, endoprosthesis
Product CodeMIR
Device Class 3

Premarket Approvals (PMA)
2020 2021 2022 2023 2024 2025
8 7 6 4 6 2

MDR Year MDR Reports MDR Events
2020 14 14
2021 13 13
2022 23 23
2023 22 22
2024 40 40
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Activation Failure 19 19
Obstruction of Flow 13 13
Device Stenosis 9 9
Complete Blockage 8 8
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 6 6
Activation Problem 5 5
Material Deformation 5 5
Insufficient Information 4 4
Separation Failure 4 4
Patient-Device Incompatibility 3 3
Break 3 3
Difficult to Open or Close 2 2
Partial Blockage 2 2
Difficult to Remove 2 2
Unintended Movement 2 2
Material Split, Cut or Torn 2 2
Fracture 2 2
Difficult to Advance 1 1
Difficult or Delayed Positioning 1 1
Material Separation 1 1
Migration 1 1
Defective Device 1 1
Use of Device Problem 1 1
Difficult to Fold, Unfold or Collapse 1 1
Infusion or Flow Problem 1 1
Difficult or Delayed Activation 1 1
Retraction Problem 1 1
Expulsion 1 1
Contamination 1 1
Separation Problem 1 1
Device Dislodged or Dislocated 1 1
Entrapment of Device 1 1
Material Twisted/Bent 1 1
Premature Activation 1 1
Activation, Positioning or Separation Problem 1 1
Device Slipped 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Detachment of Device or Device Component 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 37 37
No Clinical Signs, Symptoms or Conditions 24 24
Thrombosis/Thrombus 11 11
Stenosis 11 11
Obstruction/Occlusion 10 10
Insufficient Information 6 6
Liver Damage/Dysfunction 6 6
Foreign Body Embolism 4 4
Heart Failure/Congestive Heart Failure 3 3
Unspecified Vascular Problem 2 2
Unspecified Hepatic or Biliary Problem 2 2
Hernia 2 2
Thrombosis 2 2
High Blood Pressure/ Hypertension 2 2
Ascites 1 1
Occlusion 1 1
Peripheral Edema 1 1
High Pulmonary Arterial Wedge Pressure 1 1
No Known Impact Or Consequence To Patient 1 1
Cardiovascular Insufficiency 1 1
Foreign Body In Patient 1 1
Neck Pain 1 1
Pleural Effusion 1 1
Dyspnea 1 1
No Consequences Or Impact To Patient 1 1
Device Embedded In Tissue or Plaque 1 1
Failure of Implant 1 1
Abscess 1 1
Perforation 1 1

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