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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
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
1
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
No Apparent Adverse Event
6
6
Device Dislodged or Dislocated
6
6
Improper or Incorrect Procedure or Method
5
5
Fracture
5
5
Device Slipped
4
4
Torn Material
4
4
Component Falling
3
3
Migration or Expulsion of Device
3
3
Device Handling Problem
3
3
Material Deformation
3
3
Material Separation
2
2
Device Operates Differently Than Expected
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Material Fragmentation
2
2
Defective Device
2
2
Material Integrity Problem
2
2
Insufficient Information
2
2
Break
2
2
Malposition of Device
2
2
Activation, Positioning or Separation Problem
2
2
Positioning Problem
1
1
Difficult to Insert
1
1
Unraveled Material
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Positioning Failure
1
1
Device Damaged by Another Device
1
1
Patient-Device Incompatibility
1
1
Structural Problem
1
1
Difficult to Advance
1
1
Material Rupture
1
1
Misassembled
1
1
Difficult or Delayed Positioning
1
1
Failure to Advance
1
1
Separation Failure
1
1
Device Damaged Prior to Use
1
1
Physical Resistance/Sticking
1
1
Incomplete or Inadequate Connection
1
1
Inadequacy of Device Shape and/or Size
1
1
Activation Failure
1
1
Material Split, Cut or Torn
1
1
Fitting Problem
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
No Patient Involvement
4
4
Insufficient Information
4
4
No Consequences Or Impact To Patient
3
3
No Code Available
2
2
Stenosis
2
2
Death
1
1
Hyperplasia
1
1
Failure of Implant
1
1
Vascular Dissection
1
1
Perforation
1
1
Rupture
1
1
Foreign Body In Patient
1
1
Chest Pain
1
1
Aortic Valve Stenosis
1
1
Device Embedded In Tissue or Plaque
1
1
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