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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device stent graft, bypass, superficial femoral artery
Definition For bypassing stenosis in the superficial femoral artery via the femoral vein
Product CodeQWM
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024 2025
0 0 0 0 2 1 2

MDR Year MDR Reports MDR Events
2023 1 1
2024 16 16
2025 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Complete Blockage 5 5
Migration 4 4
Device Stenosis 3 3
Malposition of Device 2 2
Unintended Movement 2 2
Difficult to Remove 2 2
Obstruction of Flow 2 2
Failure to Unfold or Unwrap 2 2
Activation Failure 2 2
Activation, Positioning or Separation Problem 1 1
Migration or Expulsion of Device 1 1
Difficult to Advance 1 1
Insufficient Information 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Lack of Effect 1 1
Partial Blockage 1 1
Detachment of Device or Device Component 1 1
Device Dislodged or Dislocated 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Obstruction/Occlusion 9 9
Pain 6 6
No Clinical Signs, Symptoms or Conditions 5 5
Thrombosis/Thrombus 4 4
Insufficient Information 2 2
Failure of Implant 1 1
Sepsis 1 1
Necrosis 1 1
Ischemia 1 1
Stenosis 1 1

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