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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)
2019 2020 2021 2022 2023 2024
11 8 7 6 4 6

MDR Year MDR Reports MDR Events
2019 29 29
2020 14 14
2021 13 13
2022 23 23
2023 22 22
2024 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 39 39
Activation Failure 17 17
Obstruction of Flow 13 13
Complete Blockage 9 9
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 5 5
Activation Problem 4 4
Device Stenosis 4 4
Separation Failure 4 4
Patient-Device Incompatibility 4 4
Insufficient Information 4 4
Difficult to Remove 4 4
Partial Blockage 4 4
Migration 4 4
Break 3 3
Defective Device 3 3
Material Deformation 3 3
Unintended Movement 2 2
Difficult or Delayed Positioning 2 2
Material Separation 2 2
Fracture 2 2
Device Dislodged or Dislocated 2 2
Difficult to Open or Close 2 2
Device Slipped 1 1
Activation, Positioning or Separation Problem 1 1
Expulsion 1 1
Entrapment of Device 1 1
Off-Label Use 1 1
Difficult to Fold, Unfold or Collapse 1 1
Defective Component 1 1
Positioning Problem 1 1
Use of Device Problem 1 1
Difficult or Delayed Activation 1 1
Material Twisted/Bent 1 1
Retraction Problem 1 1
Detachment of Device or Device Component 1 1
Material Too Soft/Flexible 1 1
Premature Activation 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 24 24
No Clinical Signs, Symptoms or Conditions 20 20
No Code Available 15 15
Stenosis 12 12
Obstruction/Occlusion 9 9
Liver Damage/Dysfunction 6 6
Insufficient Information 6 6
Thrombosis/Thrombus 4 4
Foreign Body Embolism 4 4
Occlusion 3 3
Thrombosis 3 3
High Blood Pressure/ Hypertension 2 2
No Known Impact Or Consequence To Patient 2 2
Unspecified Hepatic or Biliary Problem 2 2
Heart Failure/Congestive Heart Failure 2 2
No Consequences Or Impact To Patient 2 2
Thrombus 2 2
Hemolysis 1 1
Failure of Implant 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Perforation 1 1
Blood Loss 1 1
Hemolytic Anemia 1 1
Neck Pain 1 1
Foreign Body In Patient 1 1
Pleural Effusion 1 1
Hernia 1 1
Abscess 1 1
Pulmonary Edema 1 1
Skin Tears 1 1
Cardiovascular Insufficiency 1 1
Ascites 1 1
Unspecified Vascular Problem 1 1

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