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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
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2023
2024
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Device
aortic stent
Definition
Coarctation of the Aorta
Product Code
PNF
Device Class
3
Premarket Approvals (PMA)
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
0
0
0
0
0
0
0
1
1
2
1
0
2
0
0
0
MDR Year
MDR Reports
MDR Events
2016
10
10
2017
15
15
2018
9
9
2019
16
16
2020
7
7
2021
6
6
2022
5
5
2023
8
8
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
12
12
Detachment Of Device Component
9
9
Device Dislodged or Dislocated
6
6
No Apparent Adverse Event
6
6
Fracture
5
5
Improper or Incorrect Procedure or Method
5
5
Device Slipped
4
4
Torn Material
4
4
Device Handling Problem
3
3
Migration or Expulsion of Device
3
3
Component Falling
3
3
Material Deformation
3
3
Material Integrity Problem
2
2
Insufficient Information
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Device Operates Differently Than Expected
2
2
Defective Device
2
2
Malposition of Device
2
2
Break
2
2
Activation, Positioning or Separation Problem
2
2
Material Fragmentation
2
2
Material Separation
2
2
Inadequacy of Device Shape and/or Size
1
1
Unraveled Material
1
1
Use of Device Problem
1
1
Fitting Problem
1
1
Device Damaged Prior to Use
1
1
Structural Problem
1
1
Failure to Advance
1
1
Separation Failure
1
1
Difficult to Insert
1
1
Misassembled
1
1
Material Rupture
1
1
Difficult or Delayed Positioning
1
1
Positioning Failure
1
1
Patient-Device Incompatibility
1
1
Device Damaged by Another Device
1
1
Difficult to Advance
1
1
Positioning Problem
1
1
Material Twisted/Bent
1
1
Activation Failure
1
1
Material Split, Cut or Torn
1
1
Physical Resistance/Sticking
1
1
Incomplete or Inadequate Connection
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
29
29
No Clinical Signs, Symptoms or Conditions
15
15
No Information
10
10
Insufficient Information
4
4
No Patient Involvement
4
4
No Consequences Or Impact To Patient
3
3
Stenosis
2
2
No Code Available
2
2
Vascular Dissection
1
1
Device Embedded In Tissue or Plaque
1
1
Rupture
1
1
Foreign Body In Patient
1
1
Aortic Valve Stenosis
1
1
Chest Pain
1
1
Death
1
1
Hyperplasia
1
1
Failure of Implant
1
1
Perforation
1
1
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