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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 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 34 34
Activation Failure 21 21
Obstruction of Flow 13 13
Device Stenosis 10 10
Appropriate Term/Code Not Available 7 7
Complete Blockage 6 6
Patient Device Interaction Problem 6 6
Activation Problem 5 5
Material Deformation 5 5
Separation Failure 4 4
Premature Activation 3 3
Break 3 3
Difficult to Remove 3 3
Activation, Positioning or Separation Problem 2 2
Material Split, Cut or Torn 2 2
Patient-Device Incompatibility 2 2
Fracture 2 2
Unintended Movement 2 2
Difficult to Open or Close 1 1
Material Too Soft/Flexible 1 1
Device Dislodged or Dislocated 1 1
Migration 1 1
Detachment of Device or Device Component 1 1
Material Separation 1 1
Retraction Problem 1 1
Partial Blockage 1 1
Difficult or Delayed Positioning 1 1
Infusion or Flow Problem 1 1
Material Twisted/Bent 1 1
Difficult or Delayed Activation 1 1
Use of Device Problem 1 1
Microbial Contamination of Device 1 1
Contamination 1 1
Defective Component 1 1
Insufficient Information 1 1
Difficult to Advance 1 1
Difficult to Fold, Unfold or Collapse 1 1
Entrapment of Device 1 1
Separation Problem 1 1
Expulsion 1 1
Device Slipped 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 31 31
No Clinical Signs, Symptoms or Conditions 28 28
Obstruction/Occlusion 11 11
Thrombosis/Thrombus 11 11
Stenosis 10 10
Liver Damage/Dysfunction 6 6
Insufficient Information 6 6
Foreign Body Embolism 4 4
Heart Failure/Congestive Heart Failure 3 3
Unspecified Vascular Problem 3 3
High Blood Pressure/ Hypertension 2 2
Hernia 2 2
Unspecified Hepatic or Biliary Problem 2 2
Failure of Implant 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Peripheral Edema 1 1
Neck Pain 1 1
Foreign Body In Patient 1 1
Pleural Effusion 1 1
Dyspnea 1 1
Cardiovascular Insufficiency 1 1
Ascites 1 1
Device Embedded In Tissue or Plaque 1 1

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