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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
0 0 0 0 2 0

MDR Year MDR Reports MDR Events
2023 1 1
2024 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Obstruction of Flow 2 2
Device Stenosis 2 2
Activation, Positioning or Separation Problem 1 1
Insufficient Information 1 1
Activation Failure 1 1
Migration 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Obstruction/Occlusion 3 3
Pain 2 2
Insufficient Information 2 2
No Clinical Signs, Symptoms or Conditions 1 1
Failure of Implant 1 1
Thrombosis/Thrombus 1 1

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