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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device aortic stent
Definition Coarctation of the Aorta
Product CodePNF
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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