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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
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
Device Dislodged or Dislocated
6
6
No Apparent Adverse Event
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
Activation, Positioning or Separation Problem
2
2
Break
2
2
Malposition of Device
2
2
Device Operates Differently Than Expected
2
2
Insufficient Information
2
2
Defective Device
2
2
Material Integrity Problem
2
2
Material Fragmentation
2
2
Material Separation
2
2
Adverse Event Without Identified Device or Use Problem
2
2
Failure to Advance
1
1
Activation Failure
1
1
Inadequacy of Device Shape and/or Size
1
1
Material Rupture
1
1
Misassembled
1
1
Difficult or Delayed Positioning
1
1
Device Damaged by Another Device
1
1
Structural Problem
1
1
Material Twisted/Bent
1
1
Use of Device Problem
1
1
Positioning Failure
1
1
Unraveled Material
1
1
Difficult to Insert
1
1
Positioning Problem
1
1
Difficult to Advance
1
1
Patient-Device Incompatibility
1
1
Separation Failure
1
1
Device Damaged Prior to Use
1
1
Incomplete or Inadequate Connection
1
1
Physical Resistance/Sticking
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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