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TPLC
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show TPLC since
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
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Device
shunt, portosystemic, endoprosthesis
Product Code
MIR
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
6
6
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
Patient-Device Incompatibility
11
11
Obstruction of Flow
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
31
31
No Code Available
18
18
No Clinical Signs, Symptoms or Conditions
16
16
Stenosis
12
12
Death
11
11
Thrombosis
9
9
Liver Damage/Dysfunction
8
8
No Consequences Or Impact To Patient
7
7
Obstruction/Occlusion
7
7
No Known Impact Or Consequence To Patient
6
6
Unspecified Infection
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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