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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
6 5 6 10 16 7 9 9 8 10 11 8 7 6 4 4

MDR Year MDR Reports MDR Events
2014 8 8
2015 6 6
2016 8 8
2017 13 13
2018 20 20
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 49 49
Activation Failure 16 16
Insufficient Information 15 15
Obstruction of Flow 13 13
Patient-Device Incompatibility 11 11
Complete Blockage 9 9
Appropriate Term/Code Not Available 7 7
Patient Device Interaction Problem 6 6
Difficult to Remove 5 5
Material Separation 4 4
Partial Blockage 4 4
Break 4 4
Defective Device 4 4
Activation, Positioning or Separation Problem 3 3
Detachment of Device or Device Component 3 3
Material Deformation 3 3
Occlusion Within Device 3 3
Migration 3 3
Unintended Movement 2 2
Activation Problem 2 2
Premature Activation 2 2
Retraction Problem 2 2
Sticking 2 2
Positioning Failure 2 2
Fracture 2 2
Kinked 2 2
Difficult to Advance 2 2
Difficult to Open or Close 2 2
Device Dislodged or Dislocated 2 2
Malposition of Device 2 2
Separation Failure 2 2
Difficult or Delayed Activation 2 2
Use of Device Problem 2 2
Improper or Incorrect Procedure or Method 1 1
Defective Component 1 1
Microbial Contamination of Device 1 1
Expulsion 1 1
Material Twisted/Bent 1 1
Positioning Problem 1 1
Pressure Problem 1 1
Entrapment of Device 1 1
Difficult to Fold, Unfold or Collapse 1 1
Difficult or Delayed Positioning 1 1
Unraveled Material 1 1
Device Slipped 1 1
Off-Label Use 1 1
Material Too Soft/Flexible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Encephalopathy 32 32
No Code Available 18 18
No Clinical Signs, Symptoms or Conditions 16 16
Stenosis 12 12
Death 11 11
Thrombosis 9 9
Obstruction/Occlusion 9 9
Liver Damage/Dysfunction 8 8
No Consequences Or Impact To Patient 7 7
Unspecified Infection 6 6
No Known Impact Or Consequence To Patient 6 6
Renal Failure 5 5
Ischemia 4 4
Occlusion 4 4
Fistula 4 4
Insufficient Information 4 4
Foreign Body Embolism 3 3
Thrombosis/Thrombus 3 3
Cardiac Arrest 3 3
Sepsis 3 3
Thrombus 3 3
Bradycardia 2 2
Abscess 2 2
Hemorrhage/Bleeding 2 2
High Blood Pressure/ Hypertension 2 2
Hypoxia 2 2
Heart Failure/Congestive Heart Failure 2 2
Unspecified Hepatic or Biliary Problem 2 2
Device Embedded In Tissue or Plaque 2 2
Necrosis 2 2
Hernia 2 2
Respiratory Failure 2 2
Blood Loss 2 2
Abdominal Distention 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Skin Tears 1 1
Ascites 1 1
Neck Pain 1 1
Low Oxygen Saturation 1 1
High Pulmonary Arterial Wedge Pressure 1 1
Therapeutic Response, Decreased 1 1
Hemolytic Anemia 1 1
Discomfort 1 1
Toxicity 1 1
Vascular Dissection 1 1
Cardiovascular Insufficiency 1 1
Failure of Implant 1 1
Hemolysis 1 1
Fever 1 1
Bacterial Infection 1 1
Biliary Cirrhosis 1 1
Pulmonary Embolism 1 1
Abdominal Pain 1 1
Dyspnea 1 1
Edema 1 1
Vomiting 1 1
Dizziness 1 1
Septic Shock 1 1
Heart Failure 1 1
Rupture 1 1
Pain 1 1
Perforation 1 1
Pleural Effusion 1 1
Pulmonary Edema 1 1
Liver Contusion 1 1
Nausea 1 1

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