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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)
2021 2022 2023 2024 2025 2026
7 6 4 6 2 0

MDR Year MDR Reports MDR Events
2021 13 13
2022 23 23
2023 22 22
2024 40 40
2025 16 16
2026 13 13

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 36 36
Activation Failure 23 23
Obstruction of Flow 13 13
Device Stenosis 10 10
Appropriate Device Problem Term/Code Not Available 7 7
Patient Device Interaction Problem 6 6
Complete Blockage 6 6
Activation Problem 4 4
Material Deformation 4 4
Separation Failure 4 4
Fracture 3 3
Break 3 3
Material Split, Cut or Torn 2 2
Premature Activation 2 2
Migration 2 2
Difficult to Remove 2 2
Patient-Device Incompatibility 2 2
Peeled/Delaminated 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
Contamination 1 1
Material Separation 1 1
Device Dislodged or Dislocated 1 1
Device Slipped 1 1
Infusion or Flow Problem 1 1
Partial Blockage 1 1
Difficult to Open or Close 1 1
Microbial Contamination of Device 1 1
Use of Device Problem 1 1
Material Fragmentation 1 1
Detachment of Device or Device Component 1 1
Unintended Movement 1 1
Material Too Soft/Flexible 1 1
Expulsion 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 34 34
Encephalopathy 33 33
Thrombosis/Thrombus 11 11
Obstruction/Occlusion 11 11
Stenosis 10 10
Insufficient Information 7 7
Liver Damage/Dysfunction 6 6
Foreign Body Embolism 4 4
Unspecified Vascular Problem 3 3
Heart Failure/Congestive Heart Failure 3 3
Reduced Blood Flow 2 2
Foreign Body In Patient 2 2
Hernia 2 2
Unspecified Hepatic or Biliary Problem 2 2
High Blood Pressure/ Hypertension 2 2
Ascites 1 1
Dyspnea 1 1
Embolism/Embolus 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Failure of Implant 1 1
Cardiovascular Dysfunction/Insufficiency 1 1
Peripheral Edema 1 1
Neck Pain 1 1
Pleural Effusion 1 1
Medical device site infection 1 1
Graft failure 1 1
Device Embedded In Tissue or Plaque 1 1

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