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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
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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