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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)
2021 2022 2023 2024 2025 2026
2 0 0 2 4 1

MDR Year MDR Reports MDR Events
2021 6 6
2022 5 5
2023 8 8
2024 1 1
2025 9 9
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Dislodged or Dislocated 9 9
No Apparent Adverse Event 4 4
Material Split, Cut or Torn 3 3
Improper or Incorrect Procedure or Method 3 3
Difficult to Insert 2 2
Device Handling Problem 2 2
Material Separation 2 2
Fracture 2 2
Device Slipped 1 1
Fitting Problem 1 1
Break 1 1
Migration or Expulsion of Device 1 1
Malposition of Device 1 1
Patient-Device Incompatibility 1 1
Difficult to Advance 1 1
Unintended Movement 1 1
Defective Device 1 1
Patient Device Interaction Problem 1 1
Material Fragmentation 1 1
Positioning Failure 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22 22
Insufficient Information 8 8
Foreign Body In Patient 1 1
Device Embedded In Tissue or Plaque 1 1

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