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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 4

MDR Year MDR Reports MDR Events
2019 29 29
2020 14 14
2021 13 13
2022 23 23
2023 22 22
2024 8 8

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 37 37
Activation Failure 15 15
Obstruction of Flow 12 12
Complete Blockage 7 7
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 5 5
Insufficient Information 4 4
Partial Blockage 4 4
Break 3 3
Difficult to Remove 3 3
Migration 3 3
Defective Device 3 3
Patient-Device Incompatibility 3 3
Material Deformation 3 3
Difficult to Open or Close 2 2
Device Dislodged or Dislocated 2 2
Unintended Movement 2 2
Separation Failure 2 2
Material Separation 2 2
Fracture 2 2
Activation Problem 2 2
Premature Activation 1 1
Off-Label Use 1 1
Difficult or Delayed Positioning 1 1
Entrapment of Device 1 1
Difficult to Fold, Unfold or Collapse 1 1
Device Slipped 1 1
Use of Device Problem 1 1
Defective Component 1 1
Difficult or Delayed Activation 1 1
Retraction Problem 1 1
Positioning Problem 1 1
Material Too Soft/Flexible 1 1
Expulsion 1 1
Material Twisted/Bent 1 1
Activation, Positioning or Separation Problem 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 23 23
No Clinical Signs, Symptoms or Conditions 16 16
No Code Available 15 15
Stenosis 11 11
Obstruction/Occlusion 8 8
Liver Damage/Dysfunction 5 5
Insufficient Information 4 4
Foreign Body Embolism 3 3
Thrombosis/Thrombus 3 3
Occlusion 3 3
Thrombosis 3 3
Thrombus 2 2
No Consequences Or Impact To Patient 2 2
High Blood Pressure/ Hypertension 2 2
No Known Impact Or Consequence To Patient 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Hepatic or Biliary Problem 2 2
Abscess 1 1
Hemolytic Anemia 1 1
Cardiovascular Insufficiency 1 1
Failure of Implant 1 1
Hemolysis 1 1
Perforation 1 1
Pleural Effusion 1 1
Pulmonary Edema 1 1
Hernia 1 1
Neck Pain 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Skin Tears 1 1
Ascites 1 1
Blood Loss 1 1
Foreign Body In Patient 1 1

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