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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 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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